Drug product
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
D-0426-2018
Product summary
- Event
- Event 78949
- Status
- Terminated
- Classification
- Class III
- Quantity
- 35,620 vials
- Official record key
drug-enforcement:D-0426-2018
Official wording
Reason: Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Code information: Lot #: ZG603, Exp 11/18
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Out-of-specification