Status
Terminated
Drug Enforcement D-131-2013
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.
Classification
Class II
Report Date
January 30, 2013
Termination Date
August 4, 2014
Product Information
- 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.
- Product quantity
- 43,075 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- West-ward Pharmaceutical Corp.
- Address
-
465 Industrial Way W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-131-2013
- Event ID
- 63871
- Recall initiation date
- December 7, 2012
- Center classification date
- January 18, 2013
- Code info
- Lot #: 68478A, 69059A, 69059B, Exp 01/16
- More code info
- —