Tacrolimus Ophthalmic Recalled Due to Sterility Assurance Concerns
Pallimed Solutions is recalling Tacrolimus Ophthalmic nationwide due to FDA inspectional findings regarding quality control 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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in a pharmaceutical product, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Pallimed Solutions is recalling Tacrolimus Ophthalmic, a pharmaceutical product manufactured in Woburn, MA. The recall covers all lots within their expiry dates and is distributed nationwide.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the inspection identified issues that impacted the assurance of sterility for the product.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Ophthalmic
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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