Pharmacy Innovations Recalls Estradiol Ophthalmic Solution Due to Sterility Concerns
Pharmacy Innovations is recalling Estradiol 0.05% ophthalmic solution nationwide due to insanitary facility conditions that compromised sterility assurance. The FDA discovered the conditions during inspection.
What this means for you
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: FDA Class II recall of a sterility-critical drug (ophthalmic solution) due to insanitary facility conditions. No illnesses or injuries have been reported. The hazard is theoretical but significant for a product requiring guaranteed sterility, meeting the rubric criterion for High.
Plain-English summary
Pharmacy Innovations is recalling Estradiol 0.05% OPH Solution (prescription ophthalmic solution) distributed nationwide. The recall was initiated because FDA inspection discovered insanitary conditions at the manufacturing facility.
The facility conditions compromised the assurance of sterility for this drug product. Estradiol ophthalmic solution is a prescription eye medication, and lack of sterility poses a risk of ocular infection to patients who use the product.
The recalled product was distributed nationwide in the USA under code t20221021@9. Patients who have received this medication should consult their healthcare provider to determine whether they may have been affected and what actions they should take.
The recalled product
- Product
- Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic
- Hazard
- sterility-concern
- insanitary-conditions
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)
- t20221021@9
Distribution
Distributed nationwide across the United States.
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