Drug 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.
D-149-2013
Product summary
- Event
- Event 63969
- Status
- Terminated
- Classification
- Class II
- Quantity
- 128,319 bottles
- Official record key
drug-enforcement:D-149-2013
Official wording
Reason: Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Code information: Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance