Why it was recalled
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Product description
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
Lot numbers, UPCs & expiration codes
Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202511399, 0202511400, 0202543553, Exp 03/18; 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225, Exp 04/18
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-0612-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 29, 2018
- FDA report date
- Apr 4, 2018
- Quantity
- 48,176 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0612-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 79635
- Address
- 1925 W Field Ct Ste 300
- Code information
- Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202511399, 0202511400, 0202543553, Exp 03/18; 0202518977, 0202538282, 0202538283, 0202538284, 0202538285, 0202543552, 0202642220, 0202642224, 0202642225, Exp 04/18
- Postal code
- 60045-4862
- Report date
- Apr 4, 2018
- Product type
- Drugs
- Recall number
- D-0612-2018
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 48,176 unit dose cups
- Termination date
- Apr 22, 2020
- Reason for recall
- Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2018