FDA-Drug2020-03-11Class II

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/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 71283-0549-2

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Hazard

Lack of Assurance of Sterility

Sold states
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Affected count
N/A
Manufactured in
1990 Westwood Blvd Ste 135, N/A, Los Angeles, CA, United States
Products
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/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 71283-0549-2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0933-2020

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