Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14
  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:
West-Ward Pharmaceutical Corp.
Reason for Recall:
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

Product Codes/Lot Numbers:

Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1414-2014

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