Drug 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
D-0492-2019
Product summary
- Firm
- Oxalis Labs
- Event
- Event 81914
- Status
- Terminated
- Classification
- Class III
- Quantity
- 53,358 bottles
- Official record key
drug-enforcement:D-0492-2019
Official wording
Reason: Defective Container; complaints of leakage.
Code information: Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
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.
Derived failure modes
-
Unknown
Defective Container; complaints of leakage.