D-0546-2025 Class II Ongoing
FDA drug recall D-0546-2025 was initiated by Strides Pharma, Inc. on Jul 9, 2025 and is designated Class II. Reason for recall: Failed Dissolution Specifications. The recall status is ongoing. Affected quantity: 6,672 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 6, 2025
- Initiation Date
- Jul 9, 2025
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0546-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026