Drug & medication recalls Moderate risk

Mometasone Furoate Topical Solution recalled over manufacturing violations

Recall date
March 25, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Cosette Pharmaceuticals, Inc. recalls Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53),…
Recall number
D-0327-2021
FDA classification
Class II
Brand / firm
Cosette Pharmaceuticals, Inc.
Sold / distributed
Nationwide in the US

Why it was recalled

CGMP Deviaitons

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

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