Drug product
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.
D0384-2015
Product summary
- Event
- Event 70465
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51 vials
- Official record key
drug-enforcement:D0384-2015
Official wording
Reason: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
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
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
Good Manufacturing Practices Deviations