Reported Nov 30, 2016 · Terminated
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician…
Sun Pharmaceutical Industries, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle
- Physician SampleNot For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8
- Lot codes and dates
- LotGHEN, 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
- Amount recalled
- 326,103 bottles
Where it was sold
- Nationwide
- NJ
Why it was recalled
Failed Stability Specifications: Low Out of Specification results for alcohol content.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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