Quadmix Injection Recalled Due to Sterility Assurance Concerns
Pallimed Solutions is recalling Quadmix Injection vials because FDA inspectional findings raised concerns about quality control procedures impacting 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 explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe).
Plain-English summary
Pallimed Solutions is recalling 2 vials of Quadmix Injection, a compounded medication manufactured in Woburn, MA. The recall covers all lots within expiry and was distributed nationwide.
The recall was initiated following FDA inspectional findings that resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency 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 return or disposal.
The recalled product
- Product
- Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Compounded Injection
- Affected units
- 2
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.
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