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Recall Observatory FDA recall evidence

Drug 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

D-0290-2015

November 12, 2014

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 69810
Status
Terminated
Classification
Class II
Quantity
92,125 vials
Official record key
drug-enforcement:D-0290-2015

Official wording

Reason: Defective Container: Vials may be missing stoppers.

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

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Vials may be missing stoppers.