Clorazepate Dipotassium Tablet
FDA Recall NDC 13107-283
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Clorazepate Dipotassium (NDC 13107-283). A significant event, classified as Class II, was initiated on Apr 24, 2024 by Aurolife Pharma Llc. The reported reason for this action was: "Discoloration: Dotted and yellow spots on tablets"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Discoloration: Dotted and yellow spots on tablets
Apr 24, 2024
May 15, 2024
6909 bottles
Recall Profile & Regulatory Data
Event ID
94500
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Batch or Lot Expiration Information
Lot# s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.
Affected Packages Involved in this Recall
13107-282-01Product
13107-282-05Product
13107-283-01Product
13107-283-05Product
13107-284-01Product
Class II Ongoing
Discoloration: Dotted and yellow spots on tablets
Apr 24, 2024
May 15, 2024
6696 bottles
Recall Profile & Regulatory Data
Event ID
94500
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.
Affected Packages Involved in this Recall
13107-282-01Product
13107-282-05Product
13107-283-01Product
13107-283-05Product
13107-284-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
