Tacrolimus 0.02% Ophthalmic Solution Recalled for Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all non-expired lots of Tacrolimus 0.02% ophthalmic solution due to quality control issues affecting 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a sterile product, which poses a significant risk of serious injury or infection.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all non-expired lots of Tacrolimus 0.02% ophthalmic solution (H20-based). The recall is being conducted due to concerns regarding quality control procedures that present a potential risk to sterility assurance.
These concerns were identified during a recent FDA inspection of the pharmacy. The recall covers all lots of sterile products compounded by the facility that have not yet expired.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Tacrolimus 0.02% opth. (H20-based)
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Ophthalmic
- Hazard
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 lot numbers within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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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