Oxalis Labs recalls Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plains…

Recall date

January 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0492-2019

FDA classification

Class III

Brand / firm

Oxalis Labs

Sold / distributed

Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.

Why it was recalled

Defective Container; complaints of leakage.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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