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
Reported: July 1, 2020 Initiated: June 10, 2020 #D-1339-2020
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.
Details
- Recalling Firm
- Crown Laboratories
- Units Affected
- 35,931 tubes
- Distribution
- Distributed Nationwide in the USA.
- Location
- Johnson City, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Crown Laboratories. Units affected: 35,931 tubes.
Why was this product recalled? ▼
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 1, 2020. Severity: Moderate. Recall number: D-1339-2020.
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