D-0511-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2017
- Initiation Date
- February 17, 2017
- Termination Date
- February 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,916 cartons
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: low out of specification dissolution results found during stability testing.
Distribution Pattern
Nationwide in the United States and Puerto Rico
Code Information
Lot # 34025762A, Exp 06/17