Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Triamcinolone Acetonide Cream USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Affected NDC
45802-0064-36
Compare with the code on your package — it is the most precise check available.
Drug: Triamcinolone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Triamcinolone Acetonide NDC 45802-0064 |
1 mg/g | Cream Topical |
Padagis Israel Pharmaceuticals Ltd | Rx |
- Recalling firm
- Padagis US LLC
- NDC code
- 45802-064-36
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1497-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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
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Class II · Moderate risk
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Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Tri-Moxi+¿
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Class II · Moderate risk
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CGMP Deviations: Potential presence of metal particulate matter
Other recalls by Padagis US LLC
All 2022 recalls
Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II · Moderate risk
Estradiol Gel
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Class III · Low risk
Triamcinolone Acetonide Cream USP
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II · Moderate risk
Trospium Chloride Extended-Release Capsules
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