Drug product
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
D-1070-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 82386
- Status
- Terminated
- Classification
- Class III
- Quantity
- 701 cartons (25 vials per carton)
- Official record key
drug-enforcement:D-1070-2019
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: T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), W31814 (exp 10/2019)
Distribution pattern: Nationwide USA and Guam
Derived failure modes
-
Potency or specification failure
out-of-specification