Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-21...

FDA Recall #D-0333-2015 — Class III — December 9, 2014

Recall #D-0333-2015 Date: December 9, 2014 Classification: Class III Status: Terminated

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.

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3,937 bottles

Distribution

Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated