Recall: D-0492-2019
Class III - Minor Violations
Class IIIClassification
2019-01-11Initiated
TerminatedStatus
Oxalis LabsFirm
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
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.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.