PlainRecalls
FDA Drug Low 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.

Reported: November 30, 2016 Initiated: October 28, 2016 #D-0148-2017

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.

Details

Units Affected
326,103 bottles
Distribution
NJ and further distributed Nationwide in the USA.
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 326,103 bottles.
Why was this product recalled?
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 30, 2016. Severity: Low. Recall number: D-0148-2017.