January 2019 FDA Recall Clobetasol Propionate by Oxalis Labs
D-0492-2019 - Defective Container; complaints of leakage.

This Class III drug recall was voluntarily initiated by Oxalis Labs on January 11, 2019 for the product Clobetasol Propionate. The FDA reported the reason for recall as defective container; complaints of leakage.. The product was distributed in Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States. and the recall is currently terminated.

Recall Number: D-0492-2019

Reason for Recall
Defective Container; complaints of leakage.
Initiated
01-11-2019
Reported
02-20-2019
Quantity
53,358 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81914
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Oxalis Labs
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
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 About Termination Date
Date that FDA officially terminated the recall.
11-06-2019
Product Description About Product Description
Full technical description of the product.
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

33342-321-86 Clobetasol Propionate
33342-321-39 Clobetasol Propionate