KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g ...
FDA Recall #D-0148-2017 — Class III — October 28, 2016
Product Description
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 for Recall
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Recalling Firm
Sun Pharmaceutical Industries, Inc. — Cranbury, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
326,103 bottles
Distribution
NJ and further distributed Nationwide in the USA.
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated