Clobetasol Propionate Cream
FDA Recall NDC 68180-956
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 68180-956). A significant event, classified as Class III, was initiated on Jan 20, 2023 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Subpotent Drug: Low assay result observed during long-term stability testing."
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
Subpotent Drug: Low assay result observed during long-term stability testing.
Jan 20, 2023
Feb 01, 2023
5720 tubes
Recall Profile & Regulatory Data
Event ID
91532
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jan 16, 2024
Product Description
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
Batch or Lot Expiration Information
Lot# : K101033; Exp 6/2024
Affected Packages Involved in this Recall
68180-956-01Product
68180-956-02Product
68180-956-03Product
68180-956-04Product
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.
