Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-0148-2017

October 28, 2016

Class III

Product summary

Firm
Sun Pharmaceutical Industries, Inc.
Event
Event 75769
Status
Terminated
Classification
Class III
Quantity
326,103 bottles
Official record key
drug-enforcement:D-0148-2017

Official wording

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

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

Distribution pattern: NJ and further distributed Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification