Home / Recalls / Akorn, Inc. / D-1469-2016

D-1469-2016 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-1469-2016 was initiated by Akorn, Inc. on Jul 27, 2016 and is designated Class III. Reason for recall: Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point The recall status is terminated (terminated Jul 21, 2017). Affected quantity: 4,045 units.

Recall Details

Product Type: Drugs
Report Date: Aug 31, 2016
Initiation Date: Jul 27, 2016
Termination Date: Jul 21, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,045 units

Product Description

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

Reason for Recall

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

Distribution Pattern

Nationwide

Code Information

Lot#: 1967800, Exp10/2016

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1469-2016
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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