Why it was recalled
Failed Dissolution Specifications; 36 month stability timepoint
Product description
Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
Lot numbers, UPCs & expiration codes
67079A; 67079B; 67079C
Where it was sold
GA
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-174-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 4, 2012
- FDA report date
- Mar 6, 2013
- Quantity
- 77531 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-174-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64106
- Address
- 465 Industrial Way W
- Code information
- 67079A; 67079B; 67079C
- Postal code
- 07724-2209
- Report date
- Mar 6, 2013
- Product type
- Drugs
- Recall number
- D-174-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 77531 bottles
- Termination date
- Jan 14, 2014
- Reason for recall
- Failed Dissolution Specifications; 36 month stability timepoint
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
- Distribution pattern
- GA
- Recall initiation date
- Dec 4, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2013