Crown Laboratories recalls Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc
Recalled July 1, 2020 · FDA recall D-1338-2020 · Crown Laboratories
Hazard
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. · FDA Class II
Units
62,274 tubes
Sold at
Distributed Nationwide in the USA.
Description
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Product
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
Manufacturer(s)
Crown Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →