Pallimed Recalls Alprostadil Injection Due to Sterility Assurance Concerns
Pallimed Solutions is recalling 408 vials of Alprostadil IN NS Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility assurance failures in injectable drugs which carry significant risk.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling 408 vials of Alprostadil IN NS Injection. The product was distributed nationwide. The recall covers all lots within their expiration dates.
The recall was initiated due to FDA inspectional findings that resulted in concerns associated with quality control procedures. Specifically, these findings impacted the assurance of sterility for the compounded injection.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Injectable
- Affected units
- 408
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)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Pallimed Solutions 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.
See all 25 products in this recall →Related recalls
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