Pallimed Solutions Recalls Trimix Injection Due to Sterility Assurance Concerns
Pallimed Solutions is recalling 862 vials of Trimix Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted 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 source text identifies the recall as FDA Class II and cites a lack of assurance of sterility, which is a significant safety hazard for an injectable drug. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk defects are classified as Severe (4).
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling 862 vials of Trimix Injection. The product was distributed nationwide. The recall covers all lots within their expiry dates.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Injectable
- Affected units
- 862
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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