Why it was recalled
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Product description
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
Lot numbers, UPCs & expiration codes
Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.
Where it was sold
Nationwide
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-1440-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 3, 2014
- FDA report date
- Jul 23, 2014
- Quantity
- 111,388 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fougera Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1440-2014, exactly as published.
Show all FDA fields
- City
- Melville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68683
- Address
- 60 Baylis Rd
- Code information
- Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.
- Postal code
- 11747-3838
- Report date
- Jul 23, 2014
- Product type
- Drugs
- Recall number
- D-1440-2014
- Classification
- Class III
- Recalling firm
- Fougera Pharmaceuticals Inc.
- Product quantity
- 111,388 Bottles
- Termination date
- Dec 7, 2015
- Reason for recall
- Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 3, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2014