Recalls / Class II
Class IID-189-2013
Product
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.
- Affected lot / code info
- 68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
Why it was recalled
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 18,825 bottles
- Distribution pattern
- GA
Timeline
- Recall initiated
- 2012-11-30
- FDA classified
- 2013-03-07
- Posted by FDA
- 2013-03-13
- Terminated
- 2014-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-189-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.