Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets -...
FDA Recall #D-174-2013 — Class II — December 4, 2012
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
Recalling Firm
West-ward Pharmaceutical Corp. — Eatontown, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
77531 bottles
Distribution
GA
Code Information
67079A; 67079B; 67079C
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated