FDA recall D-131-2013

West-ward Pharmaceutical Corp. · Class II · 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.

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

Key facts

Status: Terminated
Initiation date: 2012-12-07
Report date: 2013-01-30
Termination date: 2014-08-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-131-2013