Drug recall D-0070-2023

Class III Terminated reported Nov 30, 2022

Product

Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Reason for recall

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

Lots and codes

Lot: E026A001 Exp. 06/2023

Recall details

Recalling firm
Acella Pharmaceuticals, LLC, Alpharetta, GA
Quantity
637 cartons
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
November 14, 2022
Terminated
August 21, 2024

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