Recall Enforment Report D-0070-2023

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Acella Pharmaceuticals, LLC, originally initiated on 11-14-2022 for the 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 The product was recalled due to labeling: not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0070-202311-14-202211-30-2022Class III637 cartonsPhenytoin 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 30005Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.Ongoing
D-0069-202311-14-202211-30-2022Class III574 cartonsPhenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
42192-614Phenytoin Sodium Phenytoin SodiumInjectionIntramuscular; IntravenousAcella Pharmaceuticals, LlcHuman Prescription Drug