FDA recall D-0934-2020

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical · Class II · drug

Product

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/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 71283-0550-2

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Key facts

Status: Terminated
Initiation date: 2020-01-15
Report date: 2020-03-11
Termination date: 2023-12-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Los Angeles, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0934-2020