Product: PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Reason for recall: Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Recall initiated: 20121205
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated