Why it was recalled
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Product description
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
Lot numbers, UPCs & expiration codes
Lot # 69098A, 69098B, 69100A; Exp 8/15
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-824-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 16, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 14,503 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-824-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65445
- Address
- 465 Industrial Way W
- Code information
- Lot # 69098A, 69098B, 69100A; Exp 8/15
- Postal code
- 07724-2209
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-824-2013
- Classification
- Class II
- Recalling firm
- West-Ward Pharmaceutical Corp.
- Product quantity
- 14,503 bottles
- Termination date
- Jun 23, 2014
- Reason for recall
- Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
- Distribution pattern
- Nationwide
- Recall initiation date
- May 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2013