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Pfizer Inc. recalls Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ

Recalled April 10, 2019 · FDA recall D-1071-2019 · Pfizer

Hazard
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point · FDA Class III
Units
8,878 cartons (25 vials per carton)
Sold at
Nationwide USA and Guam

Description

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

Product
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
Manufacturer(s)
Pfizer Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Pfizer Inc. recalls Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ | RecallWatchUSA