Class II Terminated

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.

Company: West-Ward Pharmaceutical Corp.
Recall Initiated: December 5, 2012
Posted: January 30, 2013
Recall Number: D-133-2013
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 60,289 bottles
Firm Location: Eatontown, NJ, United States

Reason for Recall

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.

Distribution

Nationwide and Puerto Rico

Lot / Code Info

Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15

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