Recall: D-0290-2015

Class II - Potentially Harmful

Class IIClassification

2014-11-12Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

Defective Container: Vials may be missing stoppers.

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.