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
Reported: August 6, 2025 Initiated: July 9, 2025 #D-0546-2025
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.
Details
- Recalling Firm
- Strides Pharma, Inc.
- Units Affected
- 6,672 bottles
- Distribution
- Product was distributed nationwide within the United States
- Location
- Chestnut Ridge, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Strides Pharma, Inc.. Units affected: 6,672 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 6, 2025. Severity: Moderate. Recall number: D-0546-2025.
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