AstraZeneca and Bristol-Myers Squibb Co. have recalled about 92,000 vials of their jointly marketed type 2 diabetes treatment Bydureon in several European countries because some vials weren’t fully filled with the long-acting medication.
The affected batches were recalled in the U.K., Germany, Romania, the Netherlands, Ireland, Sweden, Finland and Spain, said a Bristol-Myers spokesman. No batches distributed in other markets were affected and the companies don’t expect any supply issues, he said. There is little evidence that patient safety would be compromised as a result of injecting an under-filled vial, the spokesman said, and any health consequences would likely be minimal.
The Bydureon recall was issued after an “in-depth 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 this week by the U.K. Medicines and Healthcare Products Regulatory Agency.
Bydureon is designed to be injected once-weekly to help people with type 2 diabetes control their blood sugar. European drug regulators granted marketing authorization of the drug in 2011, while the U.S. Food and Drug Administration cleared it for sale in 2012.
News Release Bristol Myers Squibb Co Sept 19, 2013