🔍 RecallPedia

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141

Class I - Dangerous
💊 Drugs Recalled: August 17, 2013 Amneal Pharmaceuticals of New York Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Batch/Lot HL50611, exp. 1/2014
  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:
Amneal Pharmaceuticals of New York, LLC.
Reason for Recall:
Failed dissolution specifications; 18 month CRT
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141

Product Codes/Lot Numbers:

Batch/Lot HL50611, exp. 1/2014

Distribution:

Distributed in: IL, NH, NJ, NY, OH, RI, TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-66014-001

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