Drug 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
D-0070-2023
Product summary
- Event
- Event 91149
- Status
- Terminated
- Classification
- Class III
- Quantity
- 637 cartons
- Official record key
drug-enforcement:D-0070-2023
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: E026A001 Exp. 06/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Labeling or packaging
label was missing