FDA Recall Terminated Historical recordClass III
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
- Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
- Published
- March 15, 2017
- Distribution
- Nationwide
