Home / Recalls / Akorn Inc / D-1089-2017

D-1089-2017 Class III Terminated

Recalled by Akorn Inc — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
August 23, 2017
Initiation Date
July 12, 2017
Termination Date
June 19, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40,978 unit dose cups

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

Reason for Recall

Crystallization with subpotent out of specification assay results for chlorhexidine.

Distribution Pattern

Nationwide in the USA

Code Information

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

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