Clobetasol Propionate Aerosol, Foam
FDA Recall NDC 68462-625
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 Clobetasol Propionate (NDC 68462-625). A significant event, classified as Class III, was initiated on Nov 15, 2019 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Defective delivery system; product is not foaming or is coming out as liquid."
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
November 2019 Class III Recall: Defective delivery system; product is not foaming or is coming out as liquid.
Recall Number
Class III Terminated
Defective delivery system; product is not foaming or is coming out as liquid.
Nov 15, 2019
Dec 18, 2019
a) 480 packs; b) 240 packs
Recall Profile & Regulatory Data
Event ID
84282
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 15, 2024
Product Description
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# Lot 14190067, exp Jul-2021
Affected Packages Involved in this Recall
68462-625-94Product
68462-625-27Product
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.
