Drug Enforcement D-0546-2025

Failed Dissolution Specifications.

Status

Ongoing

Classification

Class II

Report Date

August 6, 2025

Termination Date

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Product Information

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
Product quantity
6,672 bottles
Reason for recall
Failed Dissolution Specifications.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Product was distributed nationwide within the United States

Location & Firm

Recalling firm
Strides Pharma, Inc.
Address
1 Ram Ridge Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0546-2025
Event ID
97215
Recall initiation date
July 9, 2025
Center classification date
July 30, 2025
Code info
Lot #: 7715893A, Exp. Date 12/31/2027
More code info
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