D-0492-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- January 11, 2019
- Termination Date
- November 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,358 bottles
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
Reason for Recall
Defective Container; complaints of leakage.
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.
Code Information
Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020