FDA recall D-0148-2017

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 for recall

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

Distribution

NJ and further distributed Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2016-10-28

Report date

2016-11-30

Termination date

2017-10-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0148-2017