Why it was recalled
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Product description
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
Lot numbers, UPCs & expiration codes
Lot #: 68028A, Exp 07/14
Where it was sold
Nationwide.
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-242-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 18, 2013
- FDA report date
- Apr 10, 2013
- Quantity
- 3, 061 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-242-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64821
- Address
- 465 Industrial Way W
- Code information
- Lot #: 68028A, Exp 07/14
- Postal code
- 07724-2209
- Report date
- Apr 10, 2013
- Product type
- Drugs
- Recall number
- D-242-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 3, 061 bottles
- Termination date
- Dec 18, 2013
- Reason for recall
- Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Mar 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 3, 2013