More US recalls as bill seeks greater FDA powers
pharmafile | January 10, 2011 | News story | Manufacturing and Production | Centocor Ortho Biotech, Cumberland Pharmaceuticals, FDA, RiteDose Corp, Sandoz, Sigma-tau Pharmasource, Teva Pharmaceuticals, manufacturing compliance, recalls
Product recalls continue to make headlines in the pharmaceutical sector, with several new incidents either side of the New Year in the US – indicating the quality issues which surfaced in 2009 and 2010 show no signs of abating.
The FDA currently has no authority to order pharmaceutical product recalls, but on January 4 gained the power to mandate food recalls as part of a broader basket of reform aimed at boosting food safety.
With a bill (HR 6543) tabled in the US Congress on 17 December 2010, seeking similar authority for medicines, greater powers in the pharmaceuticals arena may not be far behind.
In addition to recall powers, the bill would also create a registry of national and overseas drug facilities serving the US market, provide funding for more inspections of manufacturing facilities and spell out drugmakers’ responsibilities for overseeing their supply chains.
The latest crop of recalls includes:
Teva Pharmaceuticals’ recall of the antibiotic metronidazole due to potentially undersized pills, which could mean that patients taking them could receive a subtherapeutic dose and risk a worsening of their infection. The recall affects one lot of Teva’s 250mg metronidazole tablets, sold in 250-count bottles and with an expiration date of 05/2012. The Israeli generic giant is also in the midst of a recall of nearly 800,000 ProAir HFA (albuterol sulphate) asthma inhaler products because they failed content uniformity requirements.
RiteDose Corp also initiated an albuterol sulphate recall just ahead of the New Year, pulling back an estimated 6.5 million boxes of 2.5mg/3ml vials because they were wrongly labelled as containing 0.5mg/3ml, a “significant health hazard”, according to the company. Even though the correct dosing was printed on the foil overwrap, because hospitals often break down packs of individual vials for storage patients risked receiving a dose five times higher than expected, raising a risk of “tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates”.
In mid-December, Johnson & Johnson subsidiary Centocor Ortho Biotech initiated a third round of recalls for its red blood cell stimulator Procrit (epoetin alfa) injection because of the possible presence of extremely thin glass flakes – known as lamellae – in product vials. Earlier recalls affecting Procrit and Amgen’s brand of the drug Epogen took place in September and October 2010. The latest affected Procrit lots were made by Amgen Manufacturing in Juncos, Puerto Rico.
Cumberland Pharmaceuticals has recalled six lots of Acetadote (acetylcysteine) injection, a treatment to prevent or lessen liver injury after ingestion of a potentially toxic quantity of acetaminophen. Cumberland said it informed the FDA the recall is a precautionary measure based on observed particulate matter found in a very small number of vials.
Novartis’ generics subsidiary Sandoz is recalling 730,000 bottles of lorazepam 0.5mg, 1.0mg and 2.0mg in 100-count and 500-count bottles because the tablets were out-of-specification for impurities/degradation products prior to their expiry date. The firm has also recalled around 7,000 bottles of its cardiovascular drug carvedilol 25mg in 100-count bottles, made by Sandoz Pvt Ltd in India, because a capsule of another product (lansoprazole) was found in one bottle.
Sigma-tau Pharmasource has recalled one lot (4,260 vials) of its Adagen (pegademase bovine) injection for adenosine deaminase (ADA) deficiency in patients with severe combined immunodeficiency disease (SCID) because routine stability testing uncovered an elevated level of impurities.
Phil Taylor
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