Home / Recalls / Akorn Inc / D-1088-2017

D-1088-2017 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
541,900 unit dose cups (5,419 trays)

Product Description

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.

Reason for Recall

Crystallization with subpotent out of specification assay results for chlorhexidine.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 353394, Exp 10-2018

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