FDA recall record

Golden State Medical Supply Clobetasol Propionate Cream, USP, 0.05% recall — FDA D-1497-2020

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

Class IIIclassification
D-1497-2020official record ID
Aug 19, 2020report date

Recall record at a glance

Official recordD-1497-2020
CategoryDrug Recalls
ClassificationClass III
FDA record statusTerminated
Recalling firmGolden State Medical Supply Inc.
Report dateAug 19, 2020
Recall initiation dateJul 24, 2020
QuantityN/A
LocationCamarillo, CA, United States

Official product description

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.

Why the product was recalled

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

Distribution information

Nationwide within the United States

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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