Pallimed Acetylcysteine Ophthalmic Solution Recalled for Sterility Concerns
Pallimed Solutions is recalling Acetylcysteine Ophthalmic Solution due to FDA inspectional findings regarding 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. The hazard involves a lack of assurance of sterility in an ophthalmic solution, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling Acetylcysteine Ophthalmic Solution. The product is compounded in 1-vial quantities and was distributed nationwide. The recall covers all lots within their expiration dates.
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 further instructions.
The recalled product
- Product
- Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Ophthalmic Solution
- Affected units
- 1
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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