Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling 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. The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by NDC 71283-0549-2 and Lot # 12042019+533225, with an expiration date of 1/17/2020. The product was distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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
- Category
- Drug — Injectable Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 12042019+533225
- Exp 1/17/2020
Distribution
Part of a larger recall action
This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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