🔍 RecallPedia

Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152

Class I - Dangerous
💊 Drugs Recalled: October 23, 2023 The Harvard Drug Group LLC Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Reason for Recall:
Failed Content Uniformity Specifications
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152

Product Codes/Lot Numbers:

Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0153-2024

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