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.

FDA recall notice · announced February 13, 2013 · West-ward Pharmaceutical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
Quantity: 128,319 bottles
Status: Terminated
Products in this recall event:
- 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 (D-149-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.