FDA Recall D-0491-2024

Aurobindo Pharma USA Inc. · East Windsor, NJ

Class II Ongoing 750 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Lot / code: Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.

Quantity: 6696 bottles

Reason for recall

Discoloration: Dotted and yellow spots on tablets

Recall record

Recall number: D-0491-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-04-24
Classified by FDA Center: 2024-05-08
FDA published: 2024-05-15
Recalling firm: Aurobindo Pharma USA Inc.
Firm location: East Windsor, NJ

Drug identification

Brand name(s): CLORAZEPATE DIPOTASSIUM
Generic name(s): CLORAZEPATE DIPOTASSIUM
Manufacturer(s): Aurolife Pharma LLC
NDC(s): 13107-282, 13107-283, 13107-284
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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