Drug product
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
D-0546-2025
Product summary
- Event
- Event 97215
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,672 bottles
- Official record key
drug-enforcement:D-0546-2025
Official wording
Reason: Failed Dissolution Specifications.
Code information: Lot #: 7715893A, Exp. Date 12/31/2027
Distribution pattern: Product was distributed nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications