Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

Plain-English summary

Akorn Inc is recalling Halyard 24-Hour Oral Care Kits that contain 15 mL unit dose cups of 0.12% Chlorhexidine Gluconate Oral Rinse. The recall involves 101,952 unit dose cups distributed nationwide in the United States. The product was manufactured by Halyard Health Inc. and distributed by Halyard Sales, LLC.

The recall was initiated because of crystallization and subpotent out-of-specification assay results for chlorhexidine. This means the active ingredient in the affected units may not be at the intended strength. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be removed from use and returned to the distributor or disposed of according to local regulations.

The recalled product

Product

Halyard 24-Hour Oral Care Kit q4, 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 # 97014

Manufacturer

Akorn Inc

Category

Drug — Oral Rinse

Hazard

• subpotent-drug
• crystallization

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls