🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: June 10, 2020 Crown Laboratories Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: Y0378, EXP 07/2021
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Crown Laboratories
Reason for Recall:
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

Lot: Y0378, EXP 07/2021

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1339-2020

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