D0384-2015 Class II Terminated
FDA drug recall D0384-2015 was initiated by AnazaoHealth Corporation on January 26, 2015 and is designated Class II. Reason for recall: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. The recall status is terminated (terminated February 9, 2015). Affected quantity: 51 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 18, 2015
- Initiation Date
- January 26, 2015
- Termination Date
- February 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 vials
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.
Reason for Recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Distribution Pattern
Nationwide
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