Home / Recalls / Akorn, Inc. / D-0611-2018

D-0611-2018 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
56,1800 unit dose cups

Product Description

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.

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

Lot #: 350836, Exp 05/18

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