
AstraZeneca, Bristol-Myers Squibb Recall Certain Lots of Bydureon
AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.
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
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
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