Nystatin Cream recall: Subpotent
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
Why was Nystatin Cream recalled?
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: Y0378, EXP 07/2021
- 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
- Recalling firm
- Crown Laboratories
- Quantity
- 35,931 tubes
- Distribution
- Distributed Nationwide in the USA.
- Recall date
- July 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)