PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 6, 2013 Initiated: December 4, 2012 #D-174-2013

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

Reason for Recall

Failed Dissolution Specifications; 36 month stability timepoint

Details

Units Affected
77531 bottles
Distribution
GA
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by West-ward Pharmaceutical Corp.. Units affected: 77531 bottles.
Why was this product recalled?
Failed Dissolution Specifications; 36 month stability timepoint
Which agency issued this recall?
This recall was issued by the FDA Drug on March 6, 2013. Severity: Moderate. Recall number: D-174-2013.