Why it was recalled
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Product description
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl 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 numbers, UPCs & expiration codes
Lot #: 112614-1MC-82186 Exp 5/26/2015; 112614-1MC-82187 Exp 5/26/2015; 112614-1MC-82188 Exp 05/26/205 ;112614-1MC-82189 Exp 5/26/2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D0384-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2015
- FDA report date
- Feb 18, 2015
- Quantity
- 51 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AnazaoHealth Corporation
Original FDA data
Every field from FDA enforcement report D0384-2015, exactly as published.
Show all FDA fields
- City
- Las Vegas
- State
- NV
- Status
- Terminated
- Country
- United States
- Event ID
- 70465
- Address
- 7465 W Sunset Rd Ste 1200
- Code information
- Lot #: 112614-1MC-82186 Exp 5/26/2015; 112614-1MC-82187 Exp 5/26/2015; 112614-1MC-82188 Exp 05/26/205 ;112614-1MC-82189 Exp 5/26/2015
- Postal code
- 89113-1944
- Report date
- Feb 18, 2015
- Product type
- Drugs
- Recall number
- D0384-2015
- Classification
- Class II
- Recalling firm
- AnazaoHealth Corporation
- Product quantity
- 51 vials
- Termination date
- Feb 9, 2015
- Reason for recall
- Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 26, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 9, 2015