# FDA recall D-1338-2020

> **Crown Laboratories** · Class II · drug recall initiated 2020-06-10.

## Product

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

## Reason for recall

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

## Distribution

Distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-1338-2020
- **Recalling firm:** Crown Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-10
- **Report date:** 2020-07-01
- **Termination date:** 2021-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Johnson City, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1338-2020

## Citation

> AI Analytics. FDA recall D-1338-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1338-2020. Source: US FDA. Licensed CC0.

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