Axia Pharmaceutical Recalls Alprostadil Injectable Due to Sterility Concerns
Axia Pharmaceutical is recalling Alprostadil injectable vials due to a lack of assurance of sterility. The affected product is 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe (Score 4), as they are not explicitly Class I but involve significant risk.
Plain-English summary
Axia Pharmaceutical, doing business as Fusion IV Pharmaceuticals, Inc., is recalling Alprostadil (prostaglandin E1) 150 MCG/ML Injectable, For Intracavernosal Use. The product is a 2.5 mL multi-dose vial intended for prescription use only. The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by Lot # 12042019+53331 with an expiration date of 1/17/2020. The NDC number is 71283-0538-2. The product was distributed nationwide in the United States, 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Alprostadil (prostaglandin E1)150 MCG/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 71283-0538-2
- 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 #: 12042019+53331
- 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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