Drug recall D-0492-2019
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
Reason for recall
Defective Container; complaints of leakage.
Lots and codes
Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
Recall details
- Recalling firm
- Oxalis Labs, Theda, N/A
- Quantity
- 53,358 bottles
- Distribution
- Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 11, 2019
- Terminated
- November 6, 2019
Related products
- Clobetasol Propionate – drug information
- NDC 33342-321 Clobetasol Propionate · Clobetasol Propionate .4625 mg/mL · Macleods Pharmaceuticals Limited