Why it was recalled
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Product description
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Lot numbers, UPCs & expiration codes
Lot #: 71294A, Exp. 5/2017
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-1045-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 3, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1045-2017, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75261
- Address
- 401 Industrial Way West
- Code information
- Lot #: 71294A, Exp. 5/2017
- Postal code
- 07724-2209
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-1045-2017
- Classification
- Class II
- Recalling firm
- West-Ward Pharmaceuticals Corp.
- Termination date
- Dec 26, 2017
- Reason for recall
- Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 3, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 18, 2016