FDA Recalls Scopolamine Ophthalmic Solution for Sterility Assurance Issues
Pharmacy Innovations recalled Scopolamine Hydrobromide 0.25% ophthalmic solution nationwide due to FDA inspection findings of insanitary facility conditions that compromise sterility assurance.
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 with no reported illnesses or injuries, but sterility assurance for ophthalmic solutions is critical. Insanitary facility conditions create significant risk of contamination for a high-risk product directly applied to sensitive eye tissue, meeting the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pharmacy Innovations is recalling Scopolamine Hydrobromide 0.25% Ophthalmic Solution (OPH), an FDA-regulated prescription eye medication manufactured at their Erie, PA facility.
The recall was initiated after an FDA inspection revealed insanitary conditions at the manufacturing facility. These conditions raise concerns about the product's sterility assurance—a critical requirement for medications applied directly to the eye. Sterile ophthalmic solutions contaminated during manufacturing could cause serious eye infections.
This product was distributed nationwide in the USA. Patients who have received prescriptions for this medication should consult their healthcare provider or pharmacist immediately. Do not use remaining product; contact your pharmacy for return instructions or alternative medication options.
The recalled product
- Product
- SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic Solution
- Hazard
- sterility-risk
- facility-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)
- t20221111@37
Distribution
Distributed nationwide across the United States.
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