Recalls / Class III
Class IIID-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.
- Affected 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
Why it was recalled
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 326,103 bottles
- Distribution pattern
- NJ and further distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2016-10-28
- FDA classified
- 2016-11-22
- Posted by FDA
- 2016-11-30
- Terminated
- 2017-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0148-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.