🔍 RecallPedia

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60

Class I - Dangerous
💊 Drugs Recalled: February 22, 2017 Novel Laboratories Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
  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:
Novel Laboratories, Inc.
Reason for Recall:
Chemical Contamination
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60

Product Codes/Lot Numbers:

Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0653-2017

Related Recalls