Status
Terminated
Drug Enforcement D-189-2013
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Classification
Class II
Report Date
March 13, 2013
Termination Date
January 14, 2014
Product Information
- 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.
- Product quantity
- 18,825 bottles
- Reason for recall
- Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
- 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-189-2013
- Event ID
- 64105
- Recall initiation date
- November 30, 2012
- Center classification date
- March 7, 2013
- Code info
- 68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
- More code info
- —