Recalls / Class III
Class IIID-1440-2014
Product
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.
- Affected lot / code info
- Lot(s): 497R, 498R, Exp 01/2015; 635R, 636R, Exp 03/2015; 850R, Exp 04/2015; 073S, Exp 05/2015; 074S, Exp 06/2015.
Why it was recalled
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Recalling firm
- Firm
- Fougera Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 60 Baylis Rd, N/A, Melville, New York 11747-3838
Distribution
- Quantity
- 111,388 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-03
- FDA classified
- 2014-07-17
- Posted by FDA
- 2014-07-23
- Terminated
- 2015-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1440-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.