Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, an FDA Class II recall involving a significant risk of harm (sterility failure in an injectable drug) corresponds to a severity score of 4 (Severe), particularly given the potential for serious injury from non-sterile injections.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection, 40MCG/30MG/2MG/ML, 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 Lot # 11112019+53214 with an expiration date of 3/5/2020. The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.
This is a prescription-only medication intended for intracavernosal use. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/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 71283-0546-2
- Category
- Drug — Injectable
- Hazard
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 #: 11112019+53214
- Exp 3/5/2020
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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