Recalls / Class III
Class IIID-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
- Brand name
- Clobetasol Propionate
- Generic name
- Clobetasol Propionate
- Active ingredient
- Clobetasol Propionate
- Route
- Topical
- NDC
- 33342-321
- FDA application
- ANDA209361
- Affected lot / code info
- Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020
Why it was recalled
Defective Container; complaints of leakage.
Recalling firm
- Firm
- Oxalis Labs
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Lodhimajra, Tehsil - Baddi, Theda, N/A N/A, India
Distribution
- Quantity
- 53,358 bottles
- 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.
Timeline
- Recall initiated
- 2019-01-11
- FDA classified
- 2019-02-14
- Posted by FDA
- 2019-02-20
- Terminated
- 2019-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0492-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.