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Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: C...

FDA Recall #D-1339-2020 — Class II — June 10, 2020

Recall #D-1339-2020 Date: June 10, 2020 Classification: Class II Status: Terminated

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

Reason for Recall

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

Recalling Firm

Crown Laboratories — Johnson City, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

35,931 tubes

Distribution

Distributed Nationwide in the USA.

Code Information

Lot: Y0378, EXP 07/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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