Why it was recalled
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
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.
Lot numbers, UPCs & expiration codes
68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
Where it was sold
GA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-189-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 30, 2012
- FDA report date
- Mar 13, 2013
- Quantity
- 18,825 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-189-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64105
- Address
- 465 Industrial Way W
- Code information
- 68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013
- Postal code
- 07724-2209
- Report date
- Mar 13, 2013
- Product type
- Drugs
- Recall number
- D-189-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 18,825 bottles
- Termination date
- Jan 14, 2014
- Reason for recall
- Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- GA
- Recall initiation date
- Nov 30, 2012
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2013