D-0070-2023 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 30, 2022
- Initiation Date
- November 14, 2022
- Termination Date
- August 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 637 cartons
Product Description
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: E026A001 Exp. 06/2023