RecallDepth
Class III Terminated

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.

Company
Sun Pharmaceutical Industries, Inc.
Recall Initiated
October 28, 2016
Posted
November 30, 2016
Recall Number
D-0148-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
326,103 bottles
Firm Location
Cranbury, NJ, United States

Reason for Recall

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

Distribution

NJ and further distributed Nationwide in the USA.

Lot / Code Info

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

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