Clobetasol Propionate Aerosol, Foam
FDA Recall NDC 68462-608
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 68462-608). 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) 34521 bottles; b) 16930 bottles
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, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# a) 14190026, 14190028, 14190029, exp Feb-2021, 14190043, 14190045 exp Apr-2021 b) 14190024, 14190025, 14190027, exp Feb-2021, 14190030, 14190031, exp Mar-2021, 14190039, 14190042 exp Apr-2021, 14190047 exp May-2021, 14190062 exp Jul-2021
Affected Packages Involved in this Recall
68462-608-94Product
68462-608-27Product
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.
