D-1070-2019 Class III Terminated
FDA drug recall D-1070-2019 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: 701 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
- 701 cartons (25 vials per carton)
Product Description
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
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: T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), W31814 (exp 10/2019)