Pallimed Recalls Compounded Cyclosporine Ophthalmic Due to Sterility Concerns
Pallimed Solutions is recalling compounded Cyclosporine Ophthalmic because FDA inspections raised concerns about quality control and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 risks like sterility assurance failures in compounded medications are categorized as Severe (Score 4), particularly when specific injury reports are not explicitly detailed but the defect is structural to safety.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling compounded Cyclosporine Ophthalmic. The recall was initiated following FDA inspectional findings that identified concerns associated with quality control procedures impacting sterility assurance.
The recall covers all lots of the product within their expiry dates. The distribution pattern is listed as nationwide.
Consumers should stop using the product and contact their healthcare provider or pharmacist for guidance on alternatives or disposal.
The recalled product
- Product
- Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Compounded Medication
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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