FDA-Drug2013-01-30Class II

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.

West-ward Pharmaceutical Corp.
Hazard

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.

Sold states
Nationwide and Puerto Rico
Affected count
43,075 bottles
Manufactured in
465 Industrial Way W, N/A, Eatontown, NJ, United States
Products
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.

Official notice

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

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