Why it was recalled
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
NJ and further distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0148-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 28, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- 326,103 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0148-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75769
- Address
- 270 Prospect Plains Rd
- 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
- Postal code
- 08512-3605
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-0148-2017
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 326,103 bottles
- Termination date
- Oct 20, 2017
- Reason for recall
- Failed Stability Specifications: Low Out of Specification results for alcohol content.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- NJ and further distributed Nationwide in the USA.
- Recall initiation date
- Oct 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2016