Why it was recalled
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Product description
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
Lot numbers, UPCs & expiration codes
Lot #: 69099A, 69099B, Exp 08/15
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-170-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 7, 2013
- FDA report date
- Mar 6, 2013
- Quantity
- 6,511 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-170-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64107
- Address
- 465 Industrial Way W
- Code information
- Lot #: 69099A, 69099B, Exp 08/15
- Postal code
- 07724-2209
- Report date
- Mar 6, 2013
- Product type
- Drugs
- Recall number
- D-170-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 6,511 bottles
- Termination date
- Jan 21, 2015
- Reason for recall
- Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2013