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

Recall Number: D-1339-2020

Firm: Crown Laboratories

Classification: Class II

Status: Terminated

Report Date: 20200701

Initiation Date: 20200610

Termination Date: 20211105

Reason for Recall

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

Product Description

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