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-0511-2017
Product summary
- Event
- Event 76513
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25,916 cartons
- Official record key
drug-enforcement:D-0511-2017
Official wording
Reason: Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Code information: Lot # 34025762A, Exp 06/17
Distribution pattern: Nationwide in the United States and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification