Drug product
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.
D-0431-2017
Product summary
- Event
- Event 75872
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,800 cartons
- Official record key
drug-enforcement:D-0431-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 34027040A; Exp 10/17
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications