Recalls / Class III
Class IIID-0070-2023
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
- Brand name
- Phenytoin Sodium
- Generic name
- Phenytoin Sodium
- Active ingredient
- Phenytoin Sodium
- Route
- Intramuscular, Intravenous
- NDC
- 42192-614
- FDA application
- ANDA040573
- Affected lot / code info
- Lot: E026A001 Exp. 06/2023
Why it was recalled
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Recalling firm
- Firm
- Acella Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1880 Mcfarland Pkwy Ste 110, N/A, Alpharetta, Georgia 30005-1795
Distribution
- Quantity
- 637 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-11-14
- FDA classified
- 2022-11-23
- Posted by FDA
- 2022-11-30
- Terminated
- 2024-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0070-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.