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FDAFDA · Food and drugs·Recall number D-0492-2019

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

Published February 20, 2019 · Recall initiated: January 11, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Defective Container; complaints of leakage.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Brand
CLOBETASOL PROPIONATE
Manufacturer
Oxalis Labs
Distributor
Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.
UPC
0333342321398
Lot
Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
Risk classification
Class III
Area (FDA)
drug
Country
India

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