Drug product
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
D-1072-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 82386
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,320 cartons (25 vials per carton)
- Official record key
drug-enforcement:D-1072-2019
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 #: T96398, Exp.07/2019, T97492, Exp.04/2019, W28567, Exp. 09/2019, W31813, Exp.10/2019
Distribution pattern: Nationwide USA and Guam
Derived failure modes
-
Potency or specification failure
out-of-specification