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

D-0611-2018 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-0611-2018 was initiated by Akorn, Inc. on Mar 29, 2018 and is designated Class III. Reason for recall: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. The recall status is terminated (terminated Apr 22, 2020). Affected quantity: 56,1800 unit dose cups.

Recall Details

Product Type: Drugs
Report Date: Apr 4, 2018
Initiation Date: Mar 29, 2018
Termination Date: Apr 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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0611-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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