Multi-event July 2017 FDA Recall Drug by Akorn Inc

This Multi-event Class III drug recall was voluntarily initiated by Akorn Inc on July 12, 2017 for the product Drug. The FDA reported the reason for recall as crystallization with subpotent out of specification assay results for chlorhexidine.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1089-2017 TERMINATED D-1090-2017 TERMINATED D-1088-2017 TERMINATED

Recall Number: D-1089-2017

Reason for Recall
Crystallization with subpotent out of specification assay results for chlorhexidine.
Initiated
07-12-2017
Reported
08-23-2017
Quantity
40,978 unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77822
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lots: 0202623109, 0202623110, 0202623111, 0202630207, 0202630208, 0202630209, EXP 06-2018; 0202642227, 0202642228, 0202647413, 0202647414, 0202653433, 0202653434, EXP 07-2018.

Recall Number: D-1090-2017

Reason for Recall
Crystallization with subpotent out of specification assay results for chlorhexidine.
Initiated
07-12-2017
Reported
08-23-2017
Quantity
101,952 15 mL unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77822
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lots: 0202635072, 0202635073, EXP 06-2018; 0202630205, 0202630206, EXP 07-2018; 0202630203, 0202630204, 0202642217, 0202642218, 0202642219, 0202647410, 0202647411, EXP 08-2018; 0202647409, 0202647412, 0202653431, 0202653432, EXP 09-2018.

Recall Number: D-1088-2017

Reason for Recall
Crystallization with subpotent out of specification assay results for chlorhexidine.
Initiated
07-12-2017
Reported
08-23-2017
Quantity
541,900 unit dose cups (5,419 trays)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77822
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2018
Product Description About Product Description
Full technical description of the product.
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.

Batch or Lot Expiration Information

Lot# Lot: 353394, Exp 10-2018