FDA Recalls Alprostadil Injectable Solution Due to Sterility Assurance Concerns
FDA is recalling Alprostadil Injectable Solution vials from Moses Lake Professional Pharmacy because the agency cannot assure the sterility of the compounded drug.
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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile injectable drugs.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Alprostadil Injectable Solution, 40 MCG/ML, 10 mL vials. The product is prescribed only (Rx only) and was compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that this concern applies to all sterile human compounded drugs within their expiry dates. The distribution pattern for the recalled product is listed as nationwide.
Consumers and healthcare providers should stop using the affected Alprostadil vials and contact their healthcare provider or the recalling pharmacy for further instructions. The specific code associated with the recall is t06152015@29.
The recalled product
- Product
- ALPROSTADIL, Injectable Solution, 40 MCG/ML, 10 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 1
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 (1)
- t06152015@29
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional Pharmacy 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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