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.
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
Lot numbers, UPCs & expiration codes
Lot: E026A001 Exp. 06/2023
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0070-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 14, 2022
- FDA report date
- Nov 30, 2022
- Quantity
- 637 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Acella Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0070-2023, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 91149
- Address
- 1880 Mcfarland Pkwy Ste 110
- Code information
- Lot: E026A001 Exp. 06/2023
- Postal code
- 30005-1795
- Report date
- Nov 30, 2022
- Product type
- Drugs
- Recall number
- D-0070-2023
- Classification
- Class III
- Recalling firm
- Acella Pharmaceuticals, LLC
- Product quantity
- 637 cartons
- Termination date
- Aug 21, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Nov 14, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2022