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Recall Observatory FDA recall evidence

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

December 05, 2012

Class II

Product summary

Firm
West-ward Pharmaceutical Corp.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance