Crown Laboratories recalls Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc…

Recall date

June 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1338-2020

FDA classification

Class II

Brand / firm

Crown Laboratories

Sold / distributed

Distributed Nationwide in the USA.

Why it was recalled

Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.

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

What was recalled

Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30