KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol…

Date

Nov. 30, 2016

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Sun Pharmaceutical Industries, Inc.

Product

KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.

Reason

Failed Stability Specifications: Low Out of Specification results for alcohol content.

Distribution pattern

NJ and further distributed Nationwide in the USA.

Quantity

326,103 bottles

Codes and lots

Lot: GHEN, GLGL, GLGL-1, Exp 10/31/2016; HACS, HACS-1, HAFK, HAFK-1, Exp 1/31/2017; HDBB, HDBB-1, HDFS, HDFS-1, Exp 4/30/2017; HFDP, HFDP-1, Exp 6/30/2017

Recall started

Oct. 28, 2016

Recall number

D-0148-2017

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0148-2017. The agency record governs; check it and the company before acting.