Sun Pharmaceutical Recalls KENALOG Spray Due to Low Alcohol Content
Sun Pharmaceutical Industries is recalling KENALOG (Triamcinolone Acetonide) Spray due to low alcohol content. The product failed stability specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle. The recall involves 326,103 bottles of the product, which was distributed in New Jersey and further distributed nationwide in the USA. The specific lots affected include GHEN, GLGL, GLGL-1, HACS, HACS-1, HAFK, HAFK-1, HDBB, HDBB-1, HDFS, HDFS-1, HFDP, and HFDP-1, with expiration dates ranging from October 31, 2016, to June 30, 2017.
The reason for the recall is that the product failed stability specifications, specifically showing low out-of-specification results for alcohol content. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact Sun Pharmaceutical Industries, Inc. for further instructions or a refund. The product is labeled as 'Physician Sample: Not For Sale, Rx only,' but the recall applies to all units of the specified lots.
The recalled product
- 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.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Topical Steroid
- Affected units
- 326,103
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Distributed nationwide across the United States.
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