PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b...
FDA Recall #D-149-2013 — Class II — December 5, 2012
Product Description
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.
Recalling Firm
West-ward Pharmaceutical Corp. — Eatontown, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
128,319 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated