D-0069-2023 Class III Terminated
FDA drug recall D-0069-2023 was initiated by Acella Pharmaceuticals, LLC on November 14, 2022 and is designated Class III. 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. The recall status is terminated (terminated August 21, 2024). Affected quantity: 574 cartons.
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
- 574 cartons
Product Description
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
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: E025A001 Exp. 07/2023