Reported Jan 30, 2013 · Terminated

Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count…

West-ward Pharmaceutical Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: West-ward Pharmaceutical Corp. · 465 Industrial Way W · Eatontown, NJ · 07724-2209

Is this the product you have?

  • 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 byWest-ward Pharmaceuticals Corp. Eatontown, NJ 07724
Lot codes and dates
    • Lot #: 68478A
    • 69059A
    • 69059B
    • Exp 01/16
Amount recalled
43,075 bottles

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide
  • PR

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 4, 2014 · Data as of Sep 19, 5:53 PM UTC

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