D-1071-2019 Class III Terminated
FDA drug recall D-1071-2019 was initiated by Pfizer Inc. on March 15, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point The recall status is terminated (terminated August 11, 2022). Affected quantity: 8,878 cartons (25 vials per carton).
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2019
- Initiation Date
- March 15, 2019
- Termination Date
- August 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,878 cartons (25 vials per carton)
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Distribution Pattern
Nationwide USA and Guam
Code Information
Lot #: T97496, Exp.04/2019, T97497, Exp.07/2019, W28564(exp 09/2019), W31812, Exp. 10/2019.