🔍 RecallPedia

ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O

Class I - Dangerous
💊 Drugs Recalled: March 23, 2016 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17
  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:
Akorn, Inc.
Reason for Recall:
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O

Product Codes/Lot Numbers:

Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0874-2016

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