Home / Recalls / Akorn, Inc. / D-0333-2015

D-0333-2015 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-0333-2015 was initiated by Akorn, Inc. on Dec 9, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point. The recall status is terminated (terminated Jan 26, 2017). Affected quantity: 3,937 bottles.

Recall Details

Product Type: Drugs
Report Date: Jan 14, 2015
Initiation Date: Dec 9, 2014
Termination Date: Jan 26, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,937 bottles

Product Description

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).

Reason for Recall

Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Distribution Pattern

Nationwide

Code Information

Lots 1413900, 1417200, 1417300, Exp. 02/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0333-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

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

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