Phenytoin Sodium Injection
FDA Recall NDC 42192-614
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Phenytoin Sodium (NDC 42192-614). A significant event, classified as Class III, was initiated on Nov 14, 2022 by Acella Pharmaceuticals, Llc. The reported reason for this action was: "Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Nov 14, 2022
Nov 30, 2022
637 cartons
Recall Profile & Regulatory Data
Event ID
91149
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Aug 21, 2024
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
Batch or Lot Expiration Information
Lot# Lot: E026A001 Exp. 06/2023
Affected Packages Involved in this Recall
42192-614-10Product
42192-614-30Product
42192-614-05Product
Class III Terminated
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Nov 14, 2022
Nov 30, 2022
574 cartons
Recall Profile & Regulatory Data
Event ID
91149
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Aug 21, 2024
Product Description
Phenytoin 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 30005
Batch or Lot Expiration Information
Lot# Lot: E025A001 Exp. 07/2023
Affected Packages Involved in this Recall
42192-614-10Product
42192-614-30Product
42192-614-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
