Reported Jul 23, 2014 · Terminated
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use,…
Fougera Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fougera Pharmaceuticals Inc. · 60 Baylis Rd · Melville, NY · 11747-3838
Is this the product you have?
- 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.
- Lot codes and dates
- Lot
849RExp 04/2015
- Lot
- Amount recalled
- 3,594 Bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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