Home / Recalls / Akorn, Inc. / D-0612-2018

D-0612-2018 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
April 4, 2018
Initiation Date
March 29, 2018
Termination Date
April 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48,176 unit dose cups

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

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

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