FDAFDA · Food and drugs·Recall number D-1338-2020
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
Published July 1, 2020 · Recall initiated: June 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NYSTATIN CREAM
- Manufacturer
- Crown Laboratories
- Distributor
- Distributed Nationwide in the USA.
- UPC
- 0303160221156
- Lot
- Lot: Y0378A, EXP 07/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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