Pallimed Solutions Recalls DMSO Aqueous Irrigation 50% Due to Sterility Concerns
Pallimed Solutions is recalling DMSO Aqueous Irrigation 50% 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no injuries are reported, the lack of sterility assurance in a medical product is a significant hazard that fits the Severe category for Class II recalls with potential for serious harm.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, MA, is recalling DMSO Aqueous Irrigation 50%. The product consists of 3 vials and was distributed nationwide. The recall covers all lots within their expiration dates.
The recall was initiated because FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The source text does not specify the exact nature of the quality control failures or the specific sterility risks involved.
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 source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Affected units
- 3
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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