Home / Recalls / Akorn, Inc. / D-0916-2018

D-0916-2018 Class II Terminated

Recalled by Akorn, Inc. — Decatur, IL

FDA drug recall D-0916-2018 was initiated by Akorn, Inc. on Jun 22, 2018 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Nov 6, 2020). Affected quantity: 89,507 vials.

Recall Details

Product Type: Drugs
Report Date: Jul 18, 2018
Initiation Date: Jun 22, 2018
Termination Date: Nov 6, 2020
Product Quantity: 89,507 vials

Product Description

Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.

Reason for Recall

CGMP Deviations

Distribution Pattern

U.S. Nationwide

Code Information

Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0916-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

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

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