FDA Drug recall D0384-2015
Compounded Plaquex, intravenous injection, 50 ML vial
- FDA Drug
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of Compounded Plaquex, intravenous injection, 50 ML vial by Anazaohealth, citing good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D0384-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-26 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Anazaohealth |
| Distribution | US |
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.
Reason
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D0384-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.