Golden State Medical Supply Recalls Clobetasol Propionate Cream Due to Content Uniformity Failure
Golden State Medical Supply Inc. is recalling specific lots of Clobetasol Propionate Cream, USP, 0.05% because the bulk material failed content uniformity testing.
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 recall is classified as FDA Class III, which indicates a violation of labeling or manufacturing regulations that is not likely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Golden State Medical Supply Inc. is recalling Clobetasol Propionate Cream, USP, 0.05%, packaged in 15g and 45g tubes. The product is manufactured by Taro Pharmaceuticals Inc. in Brampton, Ontario, Canada, and marketed by Golden State Medical Supply Inc. in Camarillo, California. The recall involves two specific lots: Lot AB28535 (NDC 60429-902-15) and Lot AB40178 (NDC 60429-902-45), both with an expiration date of December 2021.
The recall was initiated because the bulk lot used to manufacture these specific product lots was found to have failed content uniformity testing. Content uniformity ensures that each unit of a pharmaceutical product contains the labeled amount of the active ingredient within an acceptable range. A failure in this test indicates that the amount of clobetasol propionate in the cream may not be consistent across the product.
The affected product was distributed nationwide within the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations. No specific instructions for patient management or alternative therapies are provided in the source text.
The recalled product
- Product
- Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
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 (3)
- Lot #: a) AB28535
- Exp. Date: Dec. 2021 b) AB40178
- Exp. Date: Dec. 2021
Distribution
Distributed nationwide across the United States.
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