Pallimed Solutions Recalls MIC with B6 and B12 Due to Sterility Concerns
Pallimed Solutions is recalling MIC with B6 and B12 vials because FDA inspectional findings raised concerns about quality control procedures and 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. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility failure in injectable compounds) are rated as Severe (4).
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling 18 vials of MIC with B6 and B12. The recall was initiated after FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.
The affected product was distributed nationwide. The recall covers all lots within the expiry date. No specific lot numbers or dates are provided in the source text.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Compounded Injectable
- Affected units
- 18
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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