Class II · Moderate risk
Kapsin Ointment
CGMP Deviations
screamin' hot
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.
Affected NDC
52099-8005
Compare with the code on your package — it is the most precise check available.
Drug: Capsaicin
- Recalling firm
- Ideaz Llc
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0834-2018 · 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 Capsaicin recalls
See all
Class II · Moderate risk
Parche Leon Pain Relieving Hot Patch
cGMP Deviations
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Other recalls by Ideaz Llc
All 2018 recalls
Class II · Moderate risk
screamin' menthol
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
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