Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-55...
FDA Recall #D-0431-2017 — Class III — December 1, 2016
Product Description
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
6,800 cartons
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot # 34027040A; Exp 10/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated