VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tabl...
FDA Recall #D-189-2013 — Class II — November 30, 2012
Product Description
VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA 30062-2260, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Reason for Recall
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
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
18,825 bottles
Distribution
GA
Code Information
68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated