Drug product
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02
D-1067-2019
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 82386
- Status
- Terminated
- Classification
- Class III
- Quantity
- 67 cartons (25 vials per carton)
- Official record key
drug-enforcement:D-1067-2019
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 #: T97469, Exp. 7/2019, W28574, Exp.09/2019
Distribution pattern: Nationwide USA and Guam
Derived failure modes
-
Potency or specification failure
out-of-specification