Recalls / Class III
Class IIID-1441-2014
Product
Triamcinolone Acetonide Lotion USP, 0.025%, 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 0168-0336-60.
- Affected lot / code info
- Lot: 849R, Exp 04/2015
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
- 3,594 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-1441-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.