24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solutio...

FDA Drug Recall #D-0613-2018 — Class III — March 29, 2018

Recall Summary

Recall Number D-0613-2018
Classification Class III — Low risk
Date Initiated March 29, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Akorn, Inc.
Location Lake Forest, IL
Product Type Drugs
Quantity 20,587 unit dose cups

Product Description

24-HOUR Oral Care q4 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 97014.

Reason for Recall

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Chlorhexidine Gluconate Oral Rinse lot # 350836, Exp 05/18 contained within kit lot #: 0202522468, 0202522470, Exp 03/18; 0202518966, 0202522469, 0202522471, 0202533449, 0202533456, 0202533463, 0202543351, 0202548200, Exp 04/18

Other Recalls from Akorn, Inc.

Recall # Classification Product Date
D-0818-2023 Class II Levofloxacin Injection 500mg/20 mL (25 mg/mL), ... Apr 26, 2023
D-0794-2023 Class II Clobetasol Propionate Cream, USP, 0.05%, packag... Apr 26, 2023
D-0790-2023 Class II Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx ... Apr 26, 2023
D-0820-2023 Class II Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bo... Apr 26, 2023
D-0849-2023 Class II Timolol Maleate Ophthalmic Solution, USP 0.5%, ... Apr 26, 2023

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.