Drug product
Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
D-1071-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 82386
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,878 cartons (25 vials per carton)
- Official record key
drug-enforcement:D-1071-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Code information: Lot #: T97496, Exp.04/2019, T97497, Exp.07/2019, W28564(exp 09/2019), W31812, Exp. 10/2019.
Distribution pattern: Nationwide USA and Guam
Derived failure modes
-
Potency or specification failure
out-of-specification