Clobetasol Propionate Solution
FDA Recall NDC 33342-321
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 33342-321). A significant event, classified as Class III, was initiated on Jan 11, 2019 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Defective Container; complaints of leakage."
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
January 2019 Class III Recall: Defective Container; complaints of leakage.
Recall Number
Class III Terminated
Defective Container; complaints of leakage.
Jan 11, 2019
Feb 20, 2019
53,358 bottles
Recall Profile & Regulatory Data
Event ID
81914
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Oxalis Labs
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.
Termination Date
Nov 06, 2019
Product Description
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86
Batch or Lot Expiration Information
Lot# Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
Affected Packages Involved in this Recall
33342-321-86Product
33342-321-39Product
3334203218Product
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.
