Drug product
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01
D-1068-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 82386
- Status
- Terminated
- Classification
- Class III
- Quantity
- 820 cartons (25 vials per carton)
- Official record key
drug-enforcement:D-1068-2019
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#: T78191, Exp.04/2019, T97494, Exp.07/2019
Distribution pattern: Nationwide USA and Guam
Derived failure modes
-
Potency or specification failure
out-of-specification