Status
Terminated
Drug Enforcement D-0070-2023
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Classification
Class III
Report Date
November 30, 2022
Termination Date
August 21, 2024
Product Information
- 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
- Product quantity
- 637 cartons
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Acella Pharmaceuticals, LLC
- Address
-
1880 Mcfarland Pkwy Ste 110, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0070-2023
- Event ID
- 91149
- Recall initiation date
- November 14, 2022
- Center classification date
- November 23, 2022
- Code info
- Lot: E026A001 Exp. 06/2023
- More code info
- —