# FDA recall D-0492-2019

> **Oxalis Labs** · Class III · drug recall initiated 2019-01-11.

## 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

- **Recall number:** D-0492-2019
- **Recalling firm:** Oxalis Labs
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0492-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0492-2019. Source: US FDA. Licensed CC0.

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