FDA Drug recall D-0492-2019
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc
- FDA Drug
- Class III
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class III recall of Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc by Oxalis Labs, citing defective Container; complaints of leakage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0492-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-11 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Oxalis Labs |
| Distribution | US |
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.
Identifiers
| ndc | 33342-321-86 |
|---|---|
| ndc | 33342-321-39 |
| ndc | 3334203218 |
| code_info | Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.