Why it was recalled
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Product 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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1414-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 20, 2014
- FDA report date
- Jul 9, 2014
- Quantity
- a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-1414-2014, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68502
- Address
- 465 Industrial Way W
- Code information
- 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
- Postal code
- 07724-2209
- Report date
- Jul 9, 2014
- Product type
- Drugs
- Recall number
- D-1414-2014
- Classification
- Class II
- Recalling firm
- West-Ward Pharmaceutical Corp.
- Product quantity
- a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
- Termination date
- May 22, 2015
- Reason for recall
- Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 20, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 1, 2014