Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine… — Class II drug recall D-0934-2020
Terminated recall by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, reported 2020-03-11, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0934-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, Los Angeles, CA, United States |
| Recall initiated | 2020-01-15 |
| Classified | 2020-03-05 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2023-12-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, DO |
| Reason classes | sterility |
| NDC | 71283-0550-02 |
| Expiration dates | 2020-01-17 |
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.