Reported Feb 18, 2015 · Terminated
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium…
AnazaoHealth Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: AnazaoHealth Corporation · 7465 W Sunset Rd Ste 1200 · Las Vegas, NV · 89113-1944
Is this the product you have?
- Compounded Plaquex, intravenous injection, 50 ML vial
- Each ml containsPhosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection
- Lot codes and dates
Lot #: 112614-1MC-82186 Exp 5/26/2015112614-1MC-82187 Exp 5/26/2015112614-1MC-82188 Exp 05/26/205112614-1MC-82189 Exp 5/26/2015
- Amount recalled
- 51 vials
Where it was sold
- Nationwide
Why it was recalled
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
This product could cause temporary or reversible health problems — stop using it.
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