Pfizer Inc. recalls Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, N…

Recall date

March 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1070-2019

FDA classification

Class III

Brand / firm

Pfizer Inc.

Sold / distributed

Nationwide USA and Guam

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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