Home / Recalls / Akorn, Inc. / D-0617-2018

D-0617-2018 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-0617-2018 was initiated by Akorn, Inc. on Mar 9, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: High out of specification results for an impurity. The recall status is terminated (terminated Aug 31, 2020). Affected quantity: 4,128 bottles.

Recall Details

Product Type: Drugs
Report Date: Mar 28, 2018
Initiation Date: Mar 9, 2018
Termination Date: Aug 31, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,128 bottles

Product Description

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.

Reason for Recall

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot# 2062900, 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-0617-2018
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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