Clindamycin Injection USP recalled over sterility concerns

Recall date

June 16, 2017

Source

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

Official notice title

Alvogen, Inc recalls Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvoge…

Recall number

D-0939-2017

FDA classification

Class II

Brand / firm

Alvogen, Inc

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69