Why it was recalled
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Product description
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
Lot numbers, UPCs & expiration codes
1000's: Catalog #1140-10; Lot #/Expiry Dates: 67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry Dates: 68064A/Jan 2015 and 68666A/May 2015.
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-883-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 30, 2013
- FDA report date
- Aug 21, 2013
- Quantity
- 1000 count bottles/61,370 and 5000 count bottles/321
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-883-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65844
- Address
- 465 Industrial Way W
- Code information
- 1000's: Catalog #1140-10; Lot #/Expiry Dates: 67328A; 67329A; 67330B; 67330C/Dec 2013; 68064B; 68065A/Jan 2014; 68666B; 68667A/May 2015; 69721A/Dec 2015 and 69722A/Jan 2016. 5000's: Catalog #1140-51; Lot #/Expiry Dates: 68064A/Jan 2015 and 68666A/May 2015.
- Postal code
- 07724-2209
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-883-2013
- Classification
- Class II
- Recalling firm
- West-Ward Pharmaceutical Corp.
- Product quantity
- 1000 count bottles/61,370 and 5000 count bottles/321
- Termination date
- Jun 23, 2014
- Reason for recall
- Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 30, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2013