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
Product summary
- 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
Out of Specification