Status
Terminated
Drug Enforcement D-839-2013
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.
Classification
Class II
Report Date
August 14, 2013
Termination Date
June 5, 2014
Product Information
- Product description
- 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,
- Product quantity
- 118 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- GA
Location & Firm
- Recalling firm
- West-ward Pharmaceutical Corp.
- Address
-
465 Industrial Way W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-839-2013
- Event ID
- 65582
- Recall initiation date
- June 4, 2013
- Center classification date
- August 2, 2013
- Code info
- Lot 69968B 03/14
- More code info
- —