Class II
Terminated
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.
- Company
- West-Ward Pharmaceutical Corp.
- Recall Initiated
- December 5, 2012
- Posted
- February 13, 2013
- Recall Number
- D-149-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 128,319 bottles
- Firm Location
- Eatontown, NJ, United States
Reason for Recall
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
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