Tacrolimus Ophthalmic Solutions Recalled for Sterility Assurance Issues
Pharmacy Innovations recalls Tacrolimus ophthalmic solutions nationwide due to potential sterility assurance issues from insanitary facility conditions found during FDA inspection.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (sterile ophthalmic solution requiring strict sterility standards) where no injuries have been reported. Per the rubric, this qualifies for Score 3 (High). While classified as FDA Class II, the absence of reported hospitalizations precludes a Score 4.
Plain-English summary
Pharmacy Innovations is recalling multiple formulations of Tacrolimus ophthalmic solutions with concentrations of 0.03%, 0.1%, and 0.02%. The recall includes human ophthalmic solutions and veterinary formulations distributed nationwide in the United States.
An FDA inspection of the manufacturing facility at 2936 W 17th St., Erie, PA, revealed insanitary conditions. These conditions compromise the assurance that the products meet the sterility requirements essential for ophthalmic medications.
The affected products are identified by specific batch codes documented in the recall. The FDA classified this as a Class II recall due to the potential health risk from non-sterile ophthalmic solutions.
The recalled product
- Product
- TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET…
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic Solution
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations 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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