Product: Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15
Reason for recall: Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Recall initiated: 20200610
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated