Atropine sulfate eye drops recalled due to facility sterility concerns
Pharmacy Innovations recalls two concentrations of atropine sulfate eye drops due to insanitary facility conditions discovered by FDA inspection. The products were distributed nationwide.
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 sterile drug recall with no reported illnesses or injuries. The insanitary facility conditions represent a risk of serious harm (contaminated eye medications can cause infections), but since no injuries have been reported, this meets the rubric criteria for a High-severity recall.
Plain-English summary
Pharmacy Innovations is recalling atropine sulfate 0.05%, 1 mL dropper and atropine sulfate 0.01%, 1 mL dropper sold as prescription-only products. The recall applies to lots identified by codes t20221025@32 and t20221025@33.
The FDA inspection of Pharmacy Innovations' facility in Erie, Pennsylvania revealed insanitary conditions. Because these products are sterile medications intended for direct eye use, the insanitary conditions create a risk that the recalled products may not meet required sterility standards.
These products were distributed nationwide. Patients should stop using the recalled eye drops and contact their healthcare provider immediately. Providers should check whether patients have received any of the affected lots and provide replacement medication as needed.
No illnesses or injuries related to these products have been reported as of the recall issuance.
The recalled product
- Product
- Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic drop
- Hazard
- sterility-failure
- contamination
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)
- t20221025@32 t20221025@33
Distribution
Distributed nationwide across the United States.
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