Class II
Terminated
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.
- Company
- West-Ward Pharmaceutical Corp.
- Recall Initiated
- December 7, 2012
- Posted
- January 30, 2013
- Recall Number
- D-131-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 43,075 bottles
- Firm Location
- Eatontown, NJ, United States
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 68478A, 69059A, 69059B, Exp 01/16
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