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
- Recalling Firm
- West-ward Pharmaceutical Corp.
- 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.
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