Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd....
FDA Recall #D-0546-2025 — Class II — July 9, 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.
Recalling Firm
Strides Pharma, Inc. — Chestnut Ridge, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,672 bottles
Distribution
Product was distributed nationwide within the United States
Code Information
Lot #: 7715893A, Exp. Date 12/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated