FDA-Drug2020-07-01Class II

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

Crown Laboratories
Hazard

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

Sold states
Distributed Nationwide in the USA.
Affected count
62,274 tubes
Manufactured in
349 Lafe Cox Dr, N/A, Johnson City, TN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1338-2020

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