Nystatin Cream
FDA Recall NDC 0316-0221
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nystatin Cream (NDC 0316-0221). A significant event, classified as Class II, was initiated on Jun 10, 2020 by Crown Laboratories. The reported reason for this action was: "Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Jun 10, 2020
Jul 01, 2020
35,931 tubes
Recall Profile & Regulatory Data
Event ID
85833
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Crown Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA.
Termination Date
Nov 05, 2021
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
Batch or Lot Expiration Information
Lot# Lot: Y0378, EXP 07/2021
Affected Packages Involved in this Recall
0316-0221-15Product
0316-0221-30Product
Class II Terminated
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Jun 10, 2020
Jul 01, 2020
62,274 tubes
Recall Profile & Regulatory Data
Event ID
85833
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Crown Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA.
Termination Date
Nov 05, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: Y0378A, EXP 07/2021
Affected Packages Involved in this Recall
0316-0221-15Product
0316-0221-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
