Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-...
FDA Recall #D-131-2013 — Class II — December 7, 2012
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.
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.
Recalling Firm
West-ward Pharmaceutical Corp. — Eatontown, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
43,075 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 68478A, 69059A, 69059B, Exp 01/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated