FDAFDA · Food and drugs·Recall number D-133-2013
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Published January 30, 2013 · Recall initiated: December 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- West-ward Pharmaceutical Corp.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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