Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
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
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
- Recalling firm
- Zero Xtreme USA
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0246-2019 · 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 chemical / undeclared recalls from 2018
All chemical / undeclared recalls
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
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