FDAFDA · Food and drugs·Recall number D-0070-2023
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
Published November 30, 2022 · Recall initiated: November 14, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PHENYTOIN SODIUM
- Manufacturer
- Acella Pharmaceuticals, LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot: E026A001 Exp. 06/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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