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Recall Observatory FDA recall evidence

Drug product

Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

D-0069-2023

November 14, 2022

Class III

Product summary

Firm
Acella Pharmaceuticals, LLC
Event
Event 91149
Status
Terminated
Classification
Class III
Quantity
574 cartons
Official record key
drug-enforcement:D-0069-2023

Official wording

Reason: Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Code information: Lot: E025A001 Exp. 07/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label was missing