D-0546-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 6, 2025
- Initiation Date
- July 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,672 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications.
Distribution Pattern
Product was distributed nationwide within the United States
Code Information
Lot #: 7715893A, Exp. Date 12/31/2027