The FDA has classified three drug recalls as Class II actions in enforcement reports released July 8, affecting injectable medications distributed in the U.S.
Here are the recalled drugs:
- Avet Pharmaceuticals methohexital sodium for injection: One lot of methohexital sodium for injection, USP 500-milligram multiple-dose vials was recalled after failing impurities and degradation specifications. The recall affects 4,284 vials distributed nationwide.
- QuVa Pharma methohexital sodium: Multiple lots of compounded methohexital sodium 100 milligram/10 milliliter were recalled because of failed impurities and degradation specifications. The products were distributed nationwide.
- Somerset Therapeutics oncology drugs: Multiple lots of pemetrexed for injection (100 milligram and 500 milligram), bortezomib for injection (3.5 milligram) and azacitidine for injection (100 milligram) were recalled because of current good manufacturing practice deviations. The recall affects 12,000 vials of 100-milligram pemetrexed, 5,020 vials of 500-milligram pemetrexed, 11,400 vials of bortezomib and 8,001 vials of azacitidine distributed nationwide.
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