Thomas Reilly Versus GlaxoSmithKline: Glaxo’s Manufacturing Processes Are Not Fit For Purpose…


 

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https://www.standard.co.uk/business/glaxosmithkline-faces-new-whistleblower-claims-over-unfair-dismissal-a3842706.html

“….A senior whistleblower at GlaxoSmithKline is suing the drugs giant over claims his warnings about allegedly dangerous botched IT projects were hushed up by his superiors who eventually ended his 16-year career at the company.

Thomas Reilly worked around the world designing, installing and troubleshooting major IT projects at GSK production plants and at its UK and US data centres.

He claims he warned for years of serious issues in IT systems in many countries that caused numerous factory shutdowns.

Yet, in a lawsuit filed against the firm in the US, he says his concerns were not properly acted upon by his superiors in Britain. In one case, he says his warnings about a Latin American plant were covered up by his manager for fear of alerting auditor PricewaterhouseCoopers….

One IT issue he warned about in 2011 in GSK’s North America Pharmaceutical arm caused a major server to become unstable, two years later causing three “crippling performance events” at factories. It was only when Reilly was despatched to fix the problem in 2013 that he discovered his original warnings had never been passed on.

“….Other major IT failures he had warned about but been ignored over covered factories in Australia, Latin America and Africa, his case alleges. Even when investigations were carried out, they were not acted upon by his manager, he claims.

When he escalated his concerns to GSK’s global compliance officer, he was told then-chief executive Sir Andrew Witty had been informed of his concerns. An investigation apparently came to nothing.

In 2015, he contacted Witty directly with his concerns that GSK’s IT systems were so fragile that they risked causing another Cidra-style crisis. Witty, he claims, sent Jason Lord, global head of corporate investigations, to the US to question him. A subsequent investigation Lord set up concluded his concerns were minor, and his employment was terminated.

The case comes as GSK awaits the outcome of a Serious Fraud Office investigation into its handling of whistleblower claims in China. British fraud investigator Peter Humphreys alleges he and his wife were jailed in China after unwittingly being hired by GSK to discredit a suspected whistleblower. He is suing GSK in the same Philadelphia court as Reilly.

Reilly’s lawyer Scott Pollins said: “We are working to vindicate Tom’s actions. We want a jury to say what he did was honourable and that he should not have been punished for it.”

 


Should GSK be called a “Harmaceutical” company instead of a pharmaceutical company?


 

Former GSK employee (turned whistle blower) Thomas Reilly’s ongoing case against GSK is perhaps the most damning (in terms of allegations against the company) that I have seen.

And that’s really saying something, considering GSK’s disturbing corporate history of seriously bad behavior!

A history that includes a 3 Billion dollar fine for fraud in 2012 (brought by whistle-blower Greg Thorpe), a 500 million dollar fine in China for bribery in 2014, an ongoing investigation by the serious fraud office UK (involving numerous other allegations), not to mention recent allegations of fraud/bribery in India (first documented on this blog before anywhere else I might add), and numerous lawsuits/controversies/scandals over the years involving harm/injury to patients/consumers of GSK drugs such as Paxil, Avandia, Myodil, Cervarix, Pandemrix, Tafenoquine, Dexedrine (all documented in 11 years blog posts on this blog).

Why do I say that Thomas Reilly’s case is possibly the most damning of all the allegations/accusations leveled against GSK for the past two decades?

I say this because these allegations shine a light on GSK’s broken manufacturing practices.

Dangerous, shoddy and broken manufacturing processes in Pharmaceuticals leads to disasters such as GSK’s infamous Cidra debacle.

In that case GSK were fined 750 million, and it was another former GSK employee- Cheryl Eckard who reported that:

“...Eckard was a quality control inspector for the company when she found trouble at Cidra in 2002. According to the CBS News coverage, Eckard found a host of mess-ups there. “All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career,” she told 60 Minutes. Tainted water was used in manufacturing, production lines were turning out too-potent or not-potent-enough drugs, employees were contaminating products and different medications were packed into the same bottles, she now says…”


..Eckard reported that the Cidra plant’s water system was contaminated, that drugs were being made in unsterile conditions, and that drugs of different strengths were being mixed in the same bottle…”


Glaxo would like us to think that Cidra was a one off, however what is most disturbing about Thomas Reilly’s lawsuit against GSK is it is obvious that Cidra certainly wasn’t a one off.

Just like Glaxo’s fraud and corruption problem, GSK’s manufacturing woes are systemic.

GSK’s entire manufacturing processes are broken because the I.T. (Information technology) infrastructure-system that underpins it -is clearly not fit for purpose. The operating systems (the computers that run Glaxo’s manufacturing) are clearly defunct.

In the Cidra case, pills were contaminated, the whole factory was a mess, and medicines were put in the wrong bottles. Who knows how many deaths, or how much harm occurred to patients, from this scandal? do you think that every bottle of GSK meds from Cidra was tracked from the factory to a patient?

Of course they weren’t. It was all covered up.

I have been blogging about GSK for over a decade, and I have noticed a pattern in the media reporting of GSK’s various drug mix ups etc over the years. Even in 2005, way before Cidra was reported about, there were reports of mix ups, and drug manufacturing problems within GSK’s facilities.

See this from the Guardian in 2005:

https://www.theguardian.com/business/2005/apr/27/health.glaxosmithklinebusiness

“…GlaxoSmithKline has been forced to warn doctors in Canada that its medicine packs may include “stray tablets” for a different disease and that this could be dangerous for asthma patients.

The drug firm has had a series of quality control issues at its manufacturing plant in Cidra, Puerto Rico, culminating in the seizure of stocks of its diabetes drug Avandamet and the antidepressant Paxil by US marshals last month.

Some of the tablets were falling apart and sometimes contained the wrong dose….”


 

As recently as 2014 there were reports of contamination of GSK’s notorious Seroxat drug from their Irish manufacturing plant in Cork, how many people were harmed from the contaminated drugs released from the malfunctioning systems at this plant? We may never know, as once again this seemed to be covered up…

see RTE news link :

https://www.rte.ie/news/2014/0402/606112-glaxosmithkline/

“….The Irish Medicines Board has confirmed that a number of batches of an anti-depressant drug being recalled by GlaxoSmithKline had been placed on the Irish market.

The recall was ordered following a warning from the US Food and Drug Administration.

It said the active ingredient for the drug, manufactured in Co Cork, may have been contaminated with a solvent from a pharmaceutical waste tank.

The anti-depressant is branded under the names Paxil and Seroxat, depending on the markets, and the active ingredient is called Paroxetine.

In a statement this evening, the IMB said it is also investigating the possibility that further batches of the drug were imported into Ireland from other EU countries.

The board said it is being informed by GlaxoSmithKline that the company is voluntarily recalling the affected batches at wholesale level.

It said it is monitoring this process.

It is understood that inspectors from the board are on site at the GlaxoSmithKline manufacturing plant at Currabinny in Co Cork, to ensure that the company’s investigation into what happened has been thorough.

They will also ensure that any additional work necessary is carried out and that measures have been taken to prevent a recurrence.

The IMB said on the basis of information available, there are no patient safety concerns arising from the potential contamination.

The batches of Paroxetine involved were manufactured in Cork between July 2011 and February 2012, and it is thought the medication manufactured from these batches may have already been consumed.

The US Food and Drug Administration has warned GlaxoSmithKline that unless the company addresses the deficiencies identified at its Currabinny plant it may withhold approval for any of its new products .

It said it may even ban existing Glaxo drugs manufactured there from the United States…”

 


 

A whistle-blower contacted me some years ago alleging that there was serious problems at another GSK plant in Ireland, Stiefel in Sligo. Those allegations also seemed to be hushed up too…

See here:

https://truthman30.wordpress.com/2015/04/17/asbestos-contamination-at-a-gsk-plant-in-sligo-ireland/

“….Last year I received an e-mail from a whistle-blower based at the GSK (Stiefel) site who claimed that there was a major contamination problem at this GSK site in Sligo in Ireland. Allegedly, there was asbestos contamination which affected a few GSK drugs that are manufactured there (and also according to these claims- if they are true- some employees health has been affected by these health and safety breaches)…”


Even as recently as just this year (2018), there were media reports of a Glaxo recall of Ventolin inhalers from a GSK factory, this time from one of the French manufacturing sites:

See here-

https://www.fiercepharma.com/manufacturing/gsk-recalls-ventolin-inhalers-u-k-and-canada

“….GlaxoSmithKline is again having issues with the manufacturing of some of its respiratory inhalers, leading it to voluntarily recall some products in the U.K. and eight other markets, but not in the U.S….”

The issue, which occurred during the assembly of the devices, involved a foil strip containing the medicine inside the device which may have been damaged, reducing the full number of doses the inhaler may deliver. The issue, which affected one day of production or about 200,000 units, has been fixed, he said. The inhalers were assembled in June of last year at GSK’s site in Evreux, France…”


Interestingly in  2015/2016 , a similar breach occurred.

https://community.aafa.org/blog/glaxosmithkline-recalls-ventolin-hfa-albuterol-sulfate-inhalers

This breach involved :

“…GlaxoSmithKline voluntary recall of two lots of Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations…”


 

Furthermore in 2017, a massive breach occurred, and this time the source of the defective GSK product came from its plant in Zebulon, North Carolina.

https://www.reuters.com/article/us-oil-opec/opec-meets-russia-and-allies-to-agree-oil-output-boost-idUSKBN1JJ07G

“….The company said it had received an elevated number of product complaints about a bulging of the outside wrapper, indicating a leak of the propellant that delivers the medicine. The recall involves three lots of the Ventolin HFA 200D inhalers manufactured at GSK’s plant in Zebulon, North Carolina.

The U.S. Food and Drug Administration has approved the voluntary “Level 2” recall, which only affects products in the United States, GSK spokesman Juan Carlos Molina said.

The defect does not pose a danger to patients, so they are not being asked to return inhalers they have already purchased.

GSK said it was trying to identify the root cause of the problem and would take corrective action.

Meanwhile, the Zebulon plant is still making the inhalers, Molina said….”

“We currently don’t anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue,” GSK said in a statement.


As recently as February of this year (2018), GSK recalled some more of its inhalers due to problems and defects in their production and manufacturing:

http://www.pharmacyinfocus.co.uk/gsk-recall/

“…GSK is recalling two specific batches of Ventolin (salbutamol) 200mcg Accuhaler devices from patients and one specific batch of Seretide (salmeterol xinafoate, fluticasone propionate) 50/250mcg Accuhaler devices from hospitals, pharmacies, dispensing practices, retailers and wholesalers….”

This action follows a manufacturing issue that may result in a small number of Accuhaler devices not delivering the full number of doses in the device.

The Accuhaler, which has a distinctive disk-like shape, is used to treat asthma, but is not widely used in the UK compared to the more commonly used Evohaler.

Dr Karen Mullen, UK Medical Director, GSK, said: “It is very easy to check whether a Ventolin Accuhaler device has come from an affected batch by checking the Lot number. Any patient who has an affected inhaler should return their inhalers to their pharmacist or dispensing practice where they will be issued with a replacement inhaler. This isn’t something we want patients to be alarmed about but it is important that we ensure our inhalers work properly for all our patients. We are committed to supplying high-quality products to our patients and sincerely regret any concern caused to them and healthcare professionals.”


“..The MHRA – the body that regulates the devices – warned that patients may find their symptoms are not relieved as normal…

https://www.bbc.com/news/health-43144944


 

In 2014, Glaxo ordered a recall of its dodgy Alli (weight loss) pill :

“…GlaxoSmithKline (GSK) Consumer Healthcare has voluntarily recalled all of its nonprescription weight-loss drug orlistat (alli) from retailers in the United States and Puerto Rico, the company announced March 27.

GSK said customers have reported that bottles of orlistat they purchased over the counter in retail stores contained tablets and capsules that were not orlistat…”


 

In 2016, GSK recalled its antibiotic Bactroban due to contamination.

Bactroban is a skin cream, therefore, people would have rubbed this contaminated product into their bodies- who knows what harm that did?

https://www.empr.com/safety-alerts-and-recalls/recall-initiated-for-antibacterial-cream-ointments/article/511204/

“…GlaxoSmithKline announced a recall of 13 lots of Bactroban (mupirocin) Nasal Ointment, Bactroban Ointment, and Bactroban Cream. This recall is a precautionary measure due to potential contamination during manufacturing….”


 

A similar Bactroban recall was issued in 2015:

https://au.gsk.com/en-au/media/press-releases/2015/pharmacy-level-recall-bactroban-cream-mupirocin-calcium-2-and-bactroban-nasal-ointment-mupirocin-calcium-2/

“…31 August 2015

GSK Australia, in consultation with the Therapeutic Goods Administration (TGA), is initiating a pharmacy level recall of five batches of Bactroban Cream and three batches of Bactroban Nasal Ointment.

GSK is undertaking this recall due to the potential for physical particulate (sub-visible) contamination of the Active Pharmaceutical Ingredient (API) used in the manufacture of Bactroban Cream and Bactroban Nasal Ointment…”


 

GSK’s toothpaste product was also recalled due to possible foreign substances in it, notably – metal. Imagine brushing your teeth with contaminated toothpaste..

http://www.airforcemedicine.af.mil/Portals/1/Documents/DECS/Alerts/Recall_Parodontax_Whitening_Fluoride_Antigingivitis_Toothpaste_Possibility_of_Presence_of_Foreign_Substance_(10_17).pdf?ver=2017-10-24-135820-957

“…USAF Dental Evaluation & Consultation Service
Recall: Parodontax Whitening (Stannous Fluoride) Daily Fluoride & Antigingivitis
Toothpaste—Possibility of the Presence of Metal in the Product
 GlaxoSmithKline issued
a Recall on Parodo ntax TP Whitening 3.4 oz
GSK, due to presence of foreign substance: possibility of the presence of metal in the product. Identify any affected product in inventory and contact the manufacturer.
GlaxoSmithKline manufacturer letter was not provided..”

 


In 2015- GSK recalled 3.5 million tubes of toothpaste because they had wood fragments in them.

“….With its deal last year to combine consumer health operations with Novartis ($NVS) in a joint venture that GlaxoSmithKline ($GSK) will run, GSK CEO Andrew Witty bet a big piece of the drugmaker’s future on products like OTC pain meds and toothpaste. While Witty has lauded the future of that operation, it has stumbled in that market with the recall of nearly 4 million tubes of toothpaste products that may give users splinters.

GSK is recalling dozens of lots–3,977,252 tubes–made up of different varieties of Biotene and Sensodyne toothpaste, from the U.S., Puerto Rico and Taiwan. According to the FDA’s most recent Enforcement Report, “fragments of wood were found when the product was extruded onto a toothbrush.” The toothpaste was actually manufactured for GSK by Oratech, a Utah-based contractor.

According to a letter to retailers posted by Smith Drugs, GSK started the recall several weeks ago but the product has been on the market for nearly two years. It was shipped from June 2013 through April of this year. GSK said it was alerted to the problem by a “small number of complaints.” In a statement today, GSK said only that it hasn’t learned of any injuries from the tainted toothpaste but is recalling the product as a precautionary measure since they may contain wood fragments….”


In 2011, there was a recall issued for 3 GSK vaccines- Synflorix, Infanrix and Fluarix because of suspected quality defects:

http://www.info.gov.hk/gia/general/201103/04/P201103040289.htm

 

“….The Department of Health (DH) today (March 4) ordered a licensed drug company, GlaxoSmithKline Ltd. (GSK), to recall from the market 144 units of three of its vaccines because of suspected quality defect.

The products to be recalled are 115 units of Fluarix vaccine (Registration No.: HK-43003; Batch No.: AFLUA510AB) from eight private practitioners and two units from Hong Kong Baptist Hospital (HKBH); 20 units of Infanrix-IPV/Hib vaccine (Registration No.: HK-47367; Batch No. A20CA598A) from Hong Kong Sanatorium and Hospital Ltd (HKSH); and two units of Synflorix vaccine (Registration No.: HK-58098; Batch No. ASPNA023DC ) from DH’s Anne Black Maternal and Child Health Centre (MCHC) and five units from Ap Lei Chau MCHC….”


In 2011, Hong Kong considered prosecuting GSK over issues with its antibiotic Augmentin:

 

https://www.fool.com/investing/general/2011/07/19/hong-kong-forces-second-gsk-recall.aspx

“…Hong Kong isn’t happy with GlaxoSmithKline ($GSK). Regulators there have ordered the drugmaker to recall an antibiotic roughly a month after they found powdered forms of the drug contaminated by chemicals known as “plasticizers.” The new recall order applies to Augmentin tablets, which also were found to be tainted by the chemicals....”


In 2014 GSK had other manufacturing issues with its nicotine product:

https://au.gsk.com/en-au/media/press-releases/2014/gsk-recalls-nicotine-lozenges-from-warehouses-and-distributors/

“…26 March 2014

GSK is in the process of voluntarily recalling from warehouses and distributors a number of batches of nicotine lozenges sold globally, after we detected manufacturing issues affecting some batches. In some cases, the lozenges were larger or smaller than GSK’s manufacturing standards….”


 

In 2015, GSK recalled its Maxinutrition product over choking concerns:

https://www.fsai.ie/news_centre/food_alerts/recall_maxinutrition_cyclone_milk.aspx

http://www.thejournal.ie/maxi-nutrition-product-recalled-2004617-Mar2015/

…GlaxoSmithKline (GSK) is recalling all batches of MaxiNutrition Cyclone Milk (strawberry flavour and chocolate flavour). In some cases one of the ingredients, creatine, has recrystallised in the product and if consumed may cause choking and injury to the mouth. A point of sale recall notice should be displayed in stores that sold this product….”

 


 

In 2013, GSK issued a warning about defects in its Childrens Panadol Baby Drops, which could lead to accidental overdose in babies…

https://www.tga.gov.au/alert/childrens-panadol-baby-drops-syringe-recall

 

“Recall – incorrectly placed dosing indicator 26 November 2013 …This update provides further specific information about the recall of Children’s Panado Baby Drops being undertaken by GlaxoSmithKline (GSK), in conjunction with the TGA, for a misaligned dosing syringe that could lead to accidental overdoses.


In 2011, GSK recalled some of its Lucozade products, in some there was a risk of mould:

https://www.beveragedaily.com/Article/2011/03/04/GSK-suggests-preservative-may-be-behind-Lucozade-recall


 

A Similar recall occurred in 2009:

http://www.scmp.com/article/693616/contaminated-lucozade-drinks-recalled

“...The Centre for Food Safety warned the public not to drink two types of Lucozade Sport Drinks after mould was found in the products. The drinks concerned are Lucozade Sport HydroActive (Citrus Fruits Flavour Drink) and Lucozade Sport HydroActive (Summer Fruits Flavour Drink), both made by GlaxoSmithKline (GSK). The company was recalling the products and had set up a hotline, 6015 6889, for customers….”


 

In 2010, GSK recalled its Warfarin tablets in NewZealand:

http://www.medsafe.govt.nz/hot/Recalls/Marevan.asp

“…2010

GlaxoSmithKline New Zealand Ltd (GSK) is recalling all Marevan (Warfarin) 3mg tablets dispensed to patients since 23 November 2009. Marevan (Warfarin) is an anticoagulant treatment used to prevent blood clots. Marevan 3mg tablets are blue in colour.

The recall of Marevan (Warfarin) 3mg tablets is due to a manufacturing problem with some tablets dispensed after 23 November 2009. The problem could result in some tablets containing a higher dose of Warfarin than intended.

If tablets with a higher dose of Warfarin are taken, patients may be more likely to experience an adverse reaction to the medicine such as abnormal bleeding or bruising, vomiting with the appearance of coffee grounds or blood, blood in the urine or stool, black tarry stools…”


 

In 2012, Glaxo recalled 394,000 bottles of a hypertension drug due to bottle mix ups:

http://moloneysolicitors.ie/glaxo-recalls-394000-bottles-of-hypertention-drug/

“….GlaxoSmithKline PLC (GSK) has recalled more than 394,200 bottles of a drug used in the treatment for high-blood pressure due to the potential for tablet mix-ups at a plant that supplies the drug. U.K-based Glaxo said on Friday last that it had issued a voluntary recall of all bottles of DynaCirc remaining in the U.S market from wholesalers, pharmacies and hospitals…..”


 

In 2015, Glaxo withdrew its flu drug due to ‘potency’ issues:

It seems this vaccine came from a Canadian plant with manufacturing issues:

http://www.iaimanagers.org/es/gsk-recalls-vaccine-made-troubled-plant-canada

http://www.vaccineconfidence.org/uk-glaxo-recalls-flu-vaccine-due-to-potency-issue/

GlaxoSmithKline (GSK) is recalling all remaining FluLaval Quadrivalent Thimerosal-Free prefilled vaccine syringes because they may offer suboptimal protection against some influenza strains, according to a company statement.

“As part of stability testing, GSK observed loss of potency below the minimum specification prior to product expiry for the B strains included in the vaccine,” the company statement notes. “The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern.”


 

In 2017, GSK announced a recall for a Meningitus Vaccine due to:

https://www.empr.com/safety-alerts-and-recalls/meningococcal-disease-neisseria-meningitidis-menveo/article/675983/

“…This recall is considered precautionary as the batch associated with the recall was subject to a “mechanical intervention executed during the aseptic filling operations, which is not supported by validation data.”

 


 

In 2014, GSK recalled batches of Eye-Mo for non-compliance with standards:

https://www.processingmagazine.com/gsk-recalls-batches-of-eye-mo-solution/

“…GSK recalls batches of Eye-Mo for ‘noncompliance’ with standards

Pharmaceutical firm GlaxoSmithKline is recalling several batches of its Eye-Mo Red Eyes Formula Ophthalmic Solution, the Food and Drug Administration said over the weekend.

The FDA, in Advisory 2014-066, said the recall covers batches of Tetrahydrozoline HCl 0.05% Ophthalmic Solution with registration number DRHR-431.

It said this stemmed from the noncompliance with good manufacturing practice issued by the Italian Medicines Agency to Societa Italiana Medicinali Scandicci, the maker of Tetrahydrozoline HCl.

“The active pharmaceutical ingredient Tetrahydrozoline HCl was used in the manufacture of Eye-Mo Red Eyes Formula Ophthalmic Solution by GlaxoSmithKline (Tianjin) Co. Ltd. China,” it said…”


Glaxo packaging defects from 2014:

https://1800theeagle.com/glaxosmithkline-recalls-improperly-child-proofed-products/

“…GlaxoSmithKline has voluntarily recalled four lots of Panadol Advance 100-count bottles in Puerto Rico. The recall for the pain relief medication was issued due to a lack of appropriate child-resistant packaging to protect against access by young children. Panadol Advance contains acetaminophen, which is required to be noted clearly on the label and given special packaging to avoid acetaminophen overdose or poisoning….”


In 2016, Glaxo was warned about contamination at its Penicillin Plant:

 

https://www.statnews.com/pharmalot/2016/07/20/glaxosmithkline-fda-contamination-penicillin/

“…GlaxoSmithKline is recalling a “small” number of batches of its Bactroban antibiotic following a harsh rebuke from US regulators about contamination at a key plant. The move comes after the US Food and Drug Administration sent a stern warning letter late last month to the drug maker about a host of quality-control problems at the facility, which is located in Worthing in the United Kingdom.

The FDA issued its missive as a follow-up to a July 2015 inspection of the facility and found what it called “significant deviations” from good manufacturing practices, according to the June 30 letter, which was posted on the agency web site yesterday. The FDA, moreover, also noted that the drug maker provided an inadequate response, despite having halted production of the antibiotic and recalling product from wholesalers last year…”

Imitrex recall from 2013 :

https://migraine.com/blog/glaxosmithkline-issues-voluntary-imitrex-recall/

“…GlaxoSmithKline has issued a voluntary recall for two lots of the migraine medication Imitrex (sumatriptan). Pre-filled syringes in the affected lots (C637078 and C632842) may be protruding through the protective packaging, affecting sterility of the product and putting patients at risk for potential infection…”


 

Glaxo Recalls then discontinues Polygrip under mounting pressure from lawsuits:

From 2010:

https://www.youhavealawyer.com/blog/2010/02/19/super-poligrip-recall/

“:…Facing increasing pressure from zinc poisoning lawsuits and critics calling for a Super Poligrip recall, GlaxoSmithKline has announced that it will discontinue all Super Poligrip denture adhesives that contain zinc….”


 

2011, Problems with Glaxo’s Lamotrigine:

https://www.chemistanddruggist.co.uk/news/gsk-recalls-two-lamotrigine-batches

“…Two batches of Lamictal 200mg have been recalled by manufacturer GlaxoSmithKline after tablets were found to have delayed dissolution.


Glaxo recalls batched of blood pressure drug in 2012:

https://www.fiercepharma.com/m-a/gsk-pulls-drug-made-at-troubled-novartis-plant

“….GlaxoSmithKline ($GSK) is the latest victim of a contract-manufacturing snafu. The company has recalled 394,230 bottles of its DynaCirc CR blood pressure drug over fears that other tablets made at the same plant might have been mixed into the packages...”

Glaxo recalls ‘wrongly labeled’ Athlete’s foot drug in 2016:

https://www.fiercepharma.com/manufacturing/gsk-recalls-athlete-foot-treatment-wrongly-labeled-for-use-jock-itch

“…GlaxoSmithKline’s consumer unit is recalling 462,732 bottles of Zeasorb AF miconazole nitrate 2% that it manufactured for its North Carolina-based Stiefel Laboratories. According to the FDA Enforcement report, some of the labels have incorrect NDC codes while some back labels incorrectly state “use for the cure of most jock itch” rather than “use for the cure of most athlete’s foot.”…”


 

In 2012, Glaxo recalls baby vaccine over fears of bacteria contamination:

https://www.smh.com.au/national/baby-vaccine-recalled-over-bacteria-fears-20121016-27p35.html

 

“….Islamabad – Ministry of National Health Services (NHS) on Tuesday directed for recall of a cough syrup named ‘Sancos’ from all pharmacies of the city on the ground that it carries more percentage of pseudoephedrine than the prescribed share, said an official on Tuesday.

The letter said that both Novartis and GSK had deliberately hidden information for several months and allowed consumption of the sub standard drug. In July 2017, they were about the failure of batches, but initiated action in January 2018....”

“…The letter further said that it is a matter of concern that the integrity of the data on which drug is marketed is questionable..”


 

In 2015, GSK closed its North Carolina plant because of contamination problems:

https://www.reuters.com/article/usa-gsk-legionnaires-idUSL1N10M2TI20150811

 

“…Aug 11 (Reuters) – Drugmaker GlaxoSmithKline closed its North Carolina factory on Tuesday after testing at a cooling tower found bacteria that causes deadly Legionnaire’s disease, a company spokeswoman said.

The Legionella bacteria was discovered during routine inspections at the site in Zebulon, N.C., GSK spokeswoman Jenni Brewer Ligday said….”


 

2017: Woman sues GSK for wrong dosage cock up-

https://www.independent.co.uk/news/business/news/glaxosmithkline-lawsuit-student-skin-burn-off-wrong-medicine-lamictal-dosage-gsk-khaliah-shaw-a7730841.html

“…A 26-year old student is reportedly suing UK pharmaceutical giant GlaxoSmithKline (GSK) after claiming she received the wrong dosage of a medication that caused her skin to burn off.

Khaliah Shaw, a graduate student at Georgia College and State University in the US, was prescribed an anti-seizure medication lamotrigine, marketed as Lamictal in the US in 2014, according to a report by 11Alive, an NBC-affiliated TV station in Atlanta….”

In 2010 GSK’s Rotarix vaccine is recalled due to Pig Virus contamination:

https://www.fiercepharma.com/manufacturing/pig-virus-contamination-halts-gsk-rotarix-use

“…Contamination has led to a temporary halt in the use of a childhood vaccine and to a separate drug recall expansion.

GlaxoSmithKline’s oral rotavirus vaccine Rotarix has been temporarily shelved in the U.S. due to a pig-virus contamination. Researchers stumbled on DNA from porcine circovirus type 1–believed nonthreatening to humans–while using new molecular detection techniques. More work is being done to determine whether the whole virus or just DNA pieces are present…:”


 

2009 – GSK recalls H1N1 Vaccine because of ‘something wrong with the batch”

https://www.ctvnews.ca/batch-of-h1n1-vaccine-pulled-after-bad-reactions-1.455952

“…More than 100,000 doses of the H1N1 vaccine are being withdrawn across the country, after Manitoba health officials announced Thursday they’d noticed a higher-than-usual number of allergic reactions from one batch.

Vaccine manufacturer GlaxoSmithKline has asked several provinces to set aside the 170,000 doses from the questionable batch.

GSK say the batch recall is a precaution an they will investigate to see whether there is something wrong with the batch….”


 

GSK accidentally dumps Polio virus into a river in 2014:

https://www.fiercepharma.com/infectious-diseases/accidental-poliovirus-dump-adds-to-gsk-s-production-woes

 

“..September is proving to be another tricky month for GlaxoSmithKline’s ($GSK) vaccine production operation. Having begun the month by revealing new problems at its Canadian flu vaccine plant and followed that up with a fine for violating the U.S. Clean Air Act last week, GSK has now accidentally dumped live poliovirus into the Belgian sewer system…”


 

GSK has mysterious ‘manufacturing issues’ with a chicken pox vaccine in 2014 :

https://www.in-pharmatechnologist.com/Article/2014/02/03/GSK-90-countries-face-vaccine-shortage-due-to-Belgian-plant-problems

 

Chicken pox


 

GSK has more manufacturing problems in its Italian plant in 2016

“…Manufacturing Problems at Plant Disrupts Production of Some GlaxoSmithKline Drugs

Published: Jun 17, 2016

Manufacturing problems at a factory in Italy have disrupted production of some GlaxoSmithKline medicines, leading to shortages of a commonly used opioid anaesthetic in Denmark.

The British drugmaker said on Friday it had temporarily suspended manufacturing at its Parma site, which makes sterile products, to investigate environmental monitoring, adding this was unrelated to risks from any medicines.

The factory has now recommenced manufacturing….”


GSK has more manufacturing problems in its Quebec factory in 2014:

“…TORONTO – The company that makes about half of Canada’s seasonal flu vaccine order and has the country’s pandemic flu vaccine contract has been issued a warning from the U.S. Food and Drug Administration over problems with bacterial contamination in its Quebec manufacturing facility…”

In 2017- The Ministry of health warns of GSK’s Boostrix Vaccine leaking due to ‘manufacturing issue’
Biosstric

2016 – GSK recalls Avandia due to due ‘to a tablet dissolution quality issue

http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Safety_Information_and_Product_Recalls/Dear_Healthcare_Professional_Letters/2016/voluntary-recallofavandia4mgrosiglitazonetabletsduetoatabletdiss.html


2010: Glaxo recalls Emo-Cort due to ‘mould contamination”

https://www.cbc.ca/news/technology/emo-cort-lotion-recalled-1.975197

“…Emo-Cort lotion recalled

GlaxoSmithKline has started to voluntarily recall lot number 5R6 of their product Emo-Cort 2.5% Lotion from the Canadian market. The company is asking wholesalers, pharmacies and hospitals to immediately stop selling the lot.

The recall follows a consumer complaint to the company regarding a brown substance in the product. Testing by GSK showed mould contamination.

“There is a potential risk of local or more widespread infection from the mould contamination in those Canadians with weakened immune systems,” the regulator said….”


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