FDA recall D-1338-2020

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

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

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