PlainRecalls
FDA Drug Moderate Class II Terminated

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20

Reported: December 17, 2014 Initiated: November 12, 2014 #D-0290-2015

Product Description

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20

Reason for Recall

Defective Container: Vials may be missing stoppers.

Details

Recalling Firm
Fresenius Kabi USA, LLC
Units Affected
92,125 vials
Distribution
Nationwide and Puerto Rico
Location
Melrose Park, IL

Frequently Asked Questions

What product was recalled?
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20. Recalled by Fresenius Kabi USA, LLC. Units affected: 92,125 vials.
Why was this product recalled?
Defective Container: Vials may be missing stoppers.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 17, 2014. Severity: Moderate. Recall number: D-0290-2015.