Gentamicin Sulfate Irrigation Recalled Due to Sterility Assurance Concerns
Pallimed Solutions is recalling Gentamicin Sulfate Irrigation nationwide because FDA inspections 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 with potential for serious health consequences (such as sterility failure in a medical product) are rated as Severe (4), particularly when no specific hospitalization reports are cited to elevate it to Critical, but the risk is significant.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling Gentamicin Sulfate Irrigation. 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 and is distributed nationwide. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
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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