CLASS II Drug recall · Reported 11 Mar 2020 · FDA Enforcement Report
Polyoxyl Lauryl Ether (Polidocanol) Injection, Laureth recalled
Fusion IV Pharmaceuticals is recalling Polyoxyl Lauryl Ether (Polidocanol) Injection, Laureth-9 (Polidocanol) 5% Injectable, For, distributed nationwide in the US. The recall was initiated on 15 Jan 2020 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
- D-0960-2020
- FDA event ID
- 84978
- Recalling firm
- Fusion IV Pharmaceuticals, Los Angeles, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2020
- FDA classified
- 5 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Jan 2020 | Recall initiated by company | |
| 5 Mar 2020 | Classified by FDA | +50 days |
| 11 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
Where it was distributed
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Questions about this recall
Is Polyoxyl Lauryl Ether (Polidocanol) Injection, Laureth-9 (Polidocanol) 5% Injectable, For recalled?
Yes. Fusion IV Pharmaceuticals recalled Polyoxyl Lauryl Ether (Polidocanol) Injection, Laureth-9 (Polidocanol) 5% Injectable, For on 15 Jan 2020. The recall is Class II and its status is Terminated. Recall number D-0960-2020.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 10152019+53126, Exp 4/6/2020
Where was it sold?
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
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 21 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 Fusion IV Pharmaceuticals
All 64| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nicotinamide Adenine Dinucleotide (PF) Injection recalled | Fusion IV Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Methylcobalamin Injection, Methylcobalamin 1 MG/ML recalled | Fusion IV Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Triamcinolone Diacetate Injectable Suspension recalled | Fusion IV Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Betamethasone Acetate/Betamethasone recalled | Fusion IV Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Methylprednisolone Acetate Injectable Suspension recalled | Fusion IV Pharmaceuticals | Foreign Material | Nationwide |