Clotrimazole And Betamethasone Dipropionate Cream
FDA Recall NDC 68462-298
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Clotrimazole And Betamethasone Dipropionate (NDC 68462-298). A significant event, classified as Class III, was initiated on Aug 07, 2019 by Glenmark Pharmaceuticals Inc. Usa. The reported reason for this action was: "Temperature Abuse: Complaints received of liquidy texture."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Temperature Abuse: Complaints received of liquidy texture.
Aug 07, 2019
Aug 21, 2019
31,224 tubes
Recall Profile & Regulatory Data
Event ID
83526
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide with the United States
Termination Date
Nov 09, 2020
Product Description
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17
Batch or Lot Expiration Information
Lot# : 05180734, Exp. 03/2020
Affected Packages Involved in this Recall
68462-298-17Product
68462-298-55Product
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.
