Alprostadil/Papaverine Hydrochloride/Phentolamine recall: Sterility Concern
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze…
Why was Alprostadil/Papaverine Hydrochloride/Phentolamine recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 12042019+533247, Exp 1/17/2020
- Product
- Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze…
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Quantity
- N/A
- Distribution
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
- Recall date
- March 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)