GloStrips ophthalmic drug recalled for active ingredient impurities
Nomax Inc is recalling GloStrips fluorescein sodium ophthalmic strips nationwide due to failure of the active pharmaceutical ingredient to meet USP standards for unspecified impurities.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing-quality defect (impurities above USP standards), which poses theoretical risk to the safety or effectiveness of the ophthalmic drug but has not caused reported harm.
Plain-English summary
GloStrips fluorescein sodium ophthalmic strips (1.0 mg per strip, Rx only) are being recalled by manufacturer Nomax Inc due to a manufacturing defect in the active pharmaceutical ingredient. The product failed quality-assurance testing when the API was found not to be manufactured in compliance with the current USP monograph in regard to unspecified impurities.
The recall affects lot #14708 with an expiration date of April 30, 2024. Approximately 6,960 cartons were distributed nationwide. These ophthalmic strips are used by eye-care professionals for diagnostic eye procedures.
Healthcare providers and patients who received product from this lot should discontinue use and consult with a healthcare provider if they have concerns about their eye health. No illnesses or injuries related to this product have been reported to date. Consumers should dispose of recalled medication according to local guidelines or consult a pharmacist for proper disposal.
The recalled product
- Product
- GLOSTRIPS (FLUORESCEIN SODIUM)
- Brand
- GLOSTRIPS
- Manufacturer
- Nomax Inc
- Category
- Drug — Ophthalmic
- Hazard
- impurities
- degradation
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 (2)
- Lot #: 14708
- Exp. 04/30/2024.
Distribution
Distributed nationwide across the United States.
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