CLASS II Drug recall · Reported 18 Feb 2015 · FDA Enforcement Report
Compounded Plaquex, intravenous injection vial recalled by AnazaoHealth
AnazaoHealth is recalling Compounded Plaquex, intravenous injection vial, distributed nationwide in the US. The recall was initiated on 26 Jan 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D0384-2015
- FDA event ID
- 70465
- Recalling firm
- AnazaoHealth, Las Vegas, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2015
- FDA classified
- 9 Feb 2015
- Reported
- 18 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jan 2015 | Recall initiated by company | |
| 9 Feb 2015 | Classified by FDA | +14 days |
| 18 Feb 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Which lots are affected?
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 was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AnazaoHealth
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | B-Complex, Thiamine HCI / Riboflavin / Niacinamide recalled | AnazaoHealth | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection recalled | AnazaoHealth | Particulate Matter | Nationwide |