Why it was recalled
Crystallization with subpotent out of specification assay results for chlorhexidine.
Product description
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
Lot numbers, UPCs & expiration codes
Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.
Where it was sold
Nationwide in the USA
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-1089-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 12, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 40,978 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-1089-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77822
- Address
- 1925 W Field Ct
- Code information
- Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.
- Postal code
- 60045-4862
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1089-2017
- Classification
- Class III
- Recalling firm
- Akorn Inc
- Product quantity
- 40,978 unit dose cups
- Termination date
- Jun 19, 2018
- Reason for recall
- Crystallization with subpotent out of specification assay results for chlorhexidine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 12, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2017