Recalls / Class II
Class IID-131-2013
Product
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.
- Affected lot / code info
- Lot #: 68478A, 69059A, 69059B, Exp 01/16
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.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 43,075 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-12-07
- FDA classified
- 2013-01-18
- Posted by FDA
- 2013-01-30
- Terminated
- 2014-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-131-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.