Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Triamcinolone Acetonide Lotion USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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 NDC
0168-0336-60
Compare with the code on your package — it is the most precise check available.
Drug: Triamcinolone Category: Eye Drops & Ophthalmic
- Recalling firm
- Fougera Pharmaceuticals Inc.
- NDC code
- 0168-0336-60
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1441-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Triamcinolone recalls
See all
Class II · Moderate risk
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Other recalls by Fougera Pharmaceuticals Inc.
All 2014 recalls
Class II · Moderate risk
Desonide Ointment
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Class II · Moderate risk
Fluocinonide Gel USP
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
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