🔍 RecallPedia

Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.

Class I - Dangerous
💊 Drugs Recalled: March 15, 2022 Teligent Pharma Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Batch: 15066, 15389 Exp. 3/31/2023; 15437, Exp. 12/31/2023; 16823, Exp. 4/30/2024; 16825, 16826, Exp. 4/30/2024
  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:
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:

Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.

Product Codes/Lot Numbers:

Batch: 15066, 15389 Exp. 3/31/2023; 15437, Exp. 12/31/2023; 16823, Exp. 4/30/2024; 16825, 16826, Exp. 4/30/2024

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0679-2022

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