Class II
Terminated
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.
This recall has been terminated (originally issued February 18, 2015).
- Company
- Anazaohealth Corporation
- Recall Initiated
- January 26, 2015
- Posted
- February 18, 2015
- Recall Number
- D0384-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 51 vials
- Firm Location
- Las Vegas, NV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Distribution
Nationwide
Lot / Code Info
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
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