Drug Enforcement D-0491-2024

Discoloration: Dotted and yellow spots on tablets

Status

Ongoing

Classification

Class II

Report Date

May 15, 2024

Termination Date

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Product Information

Product description
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.
Product quantity
6696 bottles
Reason for recall
Discoloration: Dotted and yellow spots on tablets
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Aurobindo Pharma USA Inc.
Address
279 Princeton Hightstown Rd, N/A

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

Recall number
D-0491-2024
Event ID
94500
Recall initiation date
April 24, 2024
Center classification date
May 8, 2024
Code info
Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
More code info
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