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
Product summary
- 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
label was missing