D-0546-2025 Class II Ongoing

Recalled by Strides Pharma, Inc. — Chestnut Ridge, NY

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