FDAClass IIDecember 17, 2014

Gentamicin Injection recall

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

Why was Gentamicin Injection recalled?

Defective Container: Vials may be missing stoppers.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
92,125 vials
Distribution
Nationwide and Puerto Rico
Recall date
December 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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