Recalls / Class II
Class IID-0172-2015
Product
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01
- Affected lot / code info
- Lot #68975A, #68976; Exp. 07/15
Why it was recalled
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
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
- 5,596 HDPE bottles
- Distribution pattern
- GA
Timeline
- Recall initiated
- 2014-10-02
- FDA classified
- 2014-10-30
- Posted by FDA
- 2014-11-05
- Terminated
- 2015-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0172-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.