FDA 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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-01-11

Report date

2019-02-20

Termination date

2019-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Theda, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0492-2019