Drug recall D-1339-2020

Class II Terminated reported Jul 1, 2020

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.

Lots and codes

Lot: Y0378, EXP 07/2021

Recall details

Recalling firm
Crown Laboratories, Johnson City, TN
Quantity
35,931 tubes
Distribution
Distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
June 10, 2020
Terminated
November 5, 2021

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