BiMix Injection Recalled Due to Sterility Assurance Concerns
Pallimed Solutions is recalling 246 vials of BiMix 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 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 injections) are rated as Severe (4), as they are not Class I but involve significant risk.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling 246 vials of BiMix Injection. The product was distributed nationwide. The recall is being conducted because FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.
The recall covers all lots within expiry. 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.
Consumers and healthcare providers should stop using the recalled BiMix Injection and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Injectable
- Affected units
- 246
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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