AstraZeneca, Bristol-Myers Squibb Recall Certain Lots of Bydureon

Sep 23, 2013

AstraZeneca and Bristol-Myers Squibb have voluntarily recalled about 92,000 vials of their jointly marketed Type 2 diabetes treatment Bydureon (exenatide extended-release injectable suspension) in several European countries because some vials were not fully filled.

The affected vials were recalled in the United Kingdom, Germany, Romania, the Netherlands, Ireland, Sweden, Finland, and Spain, according to Bristol-Myers Squibb. The Bydureon recall was issued after a review of manufacturing records indicated at least one of the batches may have had a very small number of under-filled vials, according to an alert distributed by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The affected lot (C164827) was a 4 x 1 single-dose kit (1 vial and 1 syringe) with an expiration date of Aug. 31, 2015. It was first distributed on July 12, 2013. The low fills impact approximately 0.2% of the batch and range between 30% and 75% of the labeled dose. MHRA is advising that remaining stocks of the affected batch should be quarantined and returned to the original supplier for credit.

No batches distributed in other markets were affected and the companies don't expect any supply issues. There is little evidence that patient safety would be compromised as a result of injecting an under-filled vial, and any health consequences would likely be minimum, according to Bristol-Myers Squibb.

Bydureon is part of the diabetes alliance between AstraZeneca and Bristol-Myers Squibb. Bristol-Myers Squibb acquired Bydureon through its 2012 acquisition of Amylin Pharmaceuticals. AstraZeneca and Bristol-Myers Squibb formed a diabetes alliance in 2007 for certain drugs and later expanded that collaboration following Bristol-Myers Squibb's acquisition of Amylin to include the diabetes portfolio of Amylin, including Bydureon.

Source: MHRA and Bristol-Myers Squibb