Clobetasol Propionate Foam Recalled for CGMP Deviations
Ingenus Pharmaceuticals is recalling 45,173 cans of Clobetasol Propionate Foam, 0.05%, nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, FDA Class II recall.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source text classifies this as FDA Class II and identifies CGMP deviations as the reason for recall. No illnesses, injuries, deaths, or hospitalization reports are mentioned in the source. CGMP deviations constitute a manufacturing/quality issue without confirmed patient harm, qualifying this as a Moderate (score 2) recall.
Plain-English summary
Ingenus Pharmaceuticals, LLC (Orlando, FL) has recalled Clobetasol Propionate Foam, 0.05%, in both 50 g and 100 g cans distributed nationwide in the USA. The recall involves 45,173 cans total across multiple lot numbers with expiration dates ranging from June 2022 through November 2022.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The recall is voluntary and was initiated by the firm.
Consumers and healthcare providers who have this product should stop using it. Patients should consult with their healthcare provider regarding alternative treatment options. The recall was terminated on August 15, 2023.
The recalled product
- Product
- Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 45,173
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 (5)
- a) Lots: 32921 Exp. 06/2022
- 33152 Exp. 08/2022
- 33340 Exp. 11/2022
- b) Lots: 33152 Exp. 08/2022
- 33340 Exp. 11/2022.
Distribution
Distributed nationwide across the United States.
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