FDA-Drug2014-12-17Class II

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

Fresenius Kabi USA, LLC
Hazard

Defective Container: Vials may be missing stoppers.

Sold states
Nationwide and Puerto Rico
Affected count
92,125 vials
Manufactured in
2045 Cornell Ave, N/A, Melrose Park, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2015

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