PlainRecalls
FDA Drug Moderate Class II Terminated

Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69

Reported: July 12, 2017 Initiated: June 16, 2017 #D-0941-2017

Product Description

Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Alvogen, Inc
Units Affected
71,825 6 mL vials
Distribution
Nationwide
Location
Pine Brook, NJ

Frequently Asked Questions

What product was recalled?
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69. Recalled by Alvogen, Inc. Units affected: 71,825 6 mL vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on July 12, 2017. Severity: Moderate. Recall number: D-0941-2017.