Drug recall D-0290-2015

Class II Terminated reported Dec 17, 2014

Product

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.

Lots and codes

Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Melrose Park, IL
Quantity
92,125 vials
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
November 12, 2014
Terminated
March 8, 2016

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