Reported Mar 11, 2020 · Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL,…
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical · 1990 Westwood Blvd Ste 135 · Los Angeles, CA · 90025-4650
Is this the product you have?
- Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2
- Lot codes and dates
Lot #: 12042019+533247Exp 1/17/2020
- Amount recalled
- N/A
This recall covers 63 products
The agency filed one notice per product. You are reading one of them; the other 62 are below.
50 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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