Recalls / Class II
Class IID-839-2013
Product
VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
- Affected lot / code info
- Lot 69968B 03/14
Why it was recalled
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
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
- 118 bottles
- Distribution pattern
- GA
Timeline
- Recall initiated
- 2013-06-04
- FDA classified
- 2013-08-02
- Posted by FDA
- 2013-08-14
- Terminated
- 2014-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-839-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.