Drug 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.
D-131-2013
Product summary
- Event
- Event 63871
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43,075 bottles
- Official record key
drug-enforcement:D-131-2013
Official wording
Reason: 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.
Code information: Lot #: 68478A, 69059A, 69059B, Exp 01/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance