Oxalis Labs Recalls Clobetasol Propionate Topical Solution Due to Leakage
Oxalis Labs is recalling 53,358 bottles of Clobetasol Propionate Topical Solution due to defective containers and complaints of leakage.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to packaging defects (leakage) without reported injuries.
Plain-English summary
Oxalis Labs is recalling 53,358 bottles of Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL. The recall is being conducted due to defective containers and complaints of leakage.
The affected product is manufactured for Macleods Pharma USA, Inc. and distributed to four major distributors in Illinois, New York, Arkansas, and Kentucky, who may have further distributed the product throughout the United States. The recall includes specific lot numbers PCA801A through PCA807A with expiration dates in December 2019 and April 2020.
Consumers should check their medication for the affected lot numbers and stop using the product if it matches the recall description. The FDA has classified this as a Class III recall, indicating that the defect is not likely to cause adverse health consequences.
The recalled product
- Product
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
- Brand
- CLOBETASOL PROPIONATE
- Manufacturer
- Oxalis Labs
- Category
- Drug — Topical Prescription
- Hazard
- Affected units
- 53,358
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot Numbers: PCA801A
- PCA802A
- PCA803A
- exp. date 12/2019
- PCA804A
- PCA805A
- PCA806A
- PCA807A
- exp. date 04/2020
UPCs (2)
- 0333342321398
- 0333342321862
Distribution
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