PlainRecalls
FDA Drug Moderate 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.

Reported: January 30, 2013 Initiated: December 7, 2012 #D-131-2013

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.

Details

Units Affected
43,075 bottles
Distribution
Nationwide and Puerto Rico
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by West-ward Pharmaceutical Corp.. Units affected: 43,075 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 30, 2013. Severity: Moderate. Recall number: D-131-2013.