Skip to content
Recall Observatory FDA recall evidence

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

January 11, 2019

Class III

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

    reason.no_named_rule · v1.0.0

    Defective Container; complaints of leakage.