Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2
Reported: March 11, 2020 Initiated: January 15, 2020 #D-0937-2020
Product Description
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Units Affected
- N/A
- Distribution
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
- Location
- Los Angeles, CA
Frequently Asked Questions
What product was recalled? ▼
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2. Recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Units affected: N/A.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 11, 2020. Severity: Moderate. Recall number: D-0937-2020.
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