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D-1338-2020 Class II Terminated

Recalled by Crown Laboratories — Johnson City, TN

Recall Details

Product Type: Drugs
Report Date: July 1, 2020
Initiation Date: June 10, 2020
Termination Date: November 5, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 62,274 tubes

Product Description

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

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the USA.

Code Information

Lot: Y0378A, EXP 07/2021