Recall: D-1338-2020

Class II - Potentially Harmful

Class IIClassification

2020-06-10Initiated

TerminatedStatus

Crown LaboratoriesFirm

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

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

Distribution

Distributed Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.