Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

Class I - Dangerous

💊 Drugs Recalled: March 15, 2022 Teligent Pharma Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Batch: a) 15122, Exp. 2/28/2022; 15475, Exp. 3/31/2022; b) 15119, Exp. 2/28/2022; 15122, Exp. 2/28/2022; 15380, Exp. 3/31/2022; c) 15380, Exp. 3/31/2022
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Teligent Pharma, Inc.
Reason for Recall:: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

Product Codes/Lot Numbers:

Batch: a) 15122, Exp. 2/28/2022; 15475, Exp. 3/31/2022; b) 15119, Exp. 2/28/2022; 15122, Exp. 2/28/2022; 15380, Exp. 3/31/2022; c) 15380, Exp. 3/31/2022