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Manufacturing issues cause recalls for Amgen, Baxter and Caraco

By Zachary Brennan+

18-Aug-2014
Last updated on 18-Aug-2014 at 09:17 GMT

None of the three recalls have resulted in adverse events.
None of the three recalls have resulted in adverse events.

All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.

To date, none of the drugs recalled have resulted in adverse events.

Amgen initiated its voluntary recall for nine lots of Aranesp prefilled syringes, which are used to treat anemia caused by kidney failure or chemotherapy. The recall comes due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.

The recall is for syringes distributed in Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and UK. 

Amgen initiated this recall after the post-release control limit established by Amgen for this testing was exceeded,” Amgen spokesman Cuyler Mayer told us. “Based on Toxicological and Medical Safety opinions, the small numbers of cellulose particles which were observed pose a very low to negligible potential risk to patients. Polyester particles pose a very low potential risk to patients.”

Baxter

Last week Baxter announced a recall of two lots of its Dianeal low calcium peritoneal dialysis solution with 2.5% Dextrose 5000mL, which is used for chronic renal failure patients.

The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process,” Baxter said in a statement.

The number of individual units within these two lots represents less than 1% of Baxter’s average annual units produced globally.

Spokesman William Rader told us: “Root cause is under investigation. To date, no adverse events or related product complaints have been associated with the recalled products. We have in place various manufacturing and quality assurance protocols to help ensure products meet usage standards, which includes visual inspection.”

Caraco

The US FDA also announced that Sun Pharma subsidiary Caraco is recalling more than 100,000 bottles of its Cephalexin capsules.

The agency said the recall is occurring because the products “were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.”

Last month Sun also recalled a chemotherapy made at an Indian plant, while in May, Sun announced that it would shutter its Detroit, Michigan plant . The company did not respond to a request for comment.

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