Why it was recalled
Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Product description
Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
Lot numbers, UPCs & expiration codes
Lot #: 68478A, 69059A, 69059B, Exp 01/16
Where it was sold
Nationwide and Puerto Rico
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-131-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 7, 2012
- FDA report date
- Jan 30, 2013
- Quantity
- 43,075 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-131-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63871
- Address
- 465 Industrial Way W
- Code information
- Lot #: 68478A, 69059A, 69059B, Exp 01/16
- Postal code
- 07724-2209
- Report date
- Jan 30, 2013
- Product type
- Drugs
- Recall number
- D-131-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 43,075 bottles
- Termination date
- Aug 4, 2014
- Reason for recall
- Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 7, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2013