Why it was recalled
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Product 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
Lot numbers, UPCs & expiration codes
Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0874-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 23, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 33,862 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0874-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73491
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17
- Postal code
- 60045-4862
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0874-2016
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 33,862 mL
- Termination date
- Nov 30, 2017
- Reason for recall
- Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 23, 2016
- Initial firm notification
- Letter
- Center classification date
- May 25, 2016