Why it was recalled
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #68975A, #68976; Exp. 07/15
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-0172-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 5,596 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-0172-2015, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69539
- Address
- 465 Industrial Way W
- Code information
- Lot #68975A, #68976; Exp. 07/15
- Postal code
- 07724-2209
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0172-2015
- Classification
- Class II
- Recalling firm
- West-Ward Pharmaceutical Corp.
- Product quantity
- 5,596 HDPE bottles
- Termination date
- Aug 3, 2015
- Reason for recall
- Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- GA
- Recall initiation date
- Oct 2, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 30, 2014