Ophthalmic Drug GloStrips Recalled for Active Ingredient Impurities
FDA recalls GloStrips (Fluorescein Sodium) ophthalmic strips due to manufacturing defects in the active pharmaceutical ingredient. The API does not meet current USP purity 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: FDA Class II recall of an ophthalmic drug due to manufacturing defect in the active pharmaceutical ingredient (unspecified impurities not meeting USP specifications). No illnesses or injuries are reported in the source; however, the failure to meet API purity standards for an eye medication represents a risk-of-harm situation.
Plain-English summary
GloStrips (Fluorescein Sodium) Ophthalmic Strips are being recalled. This is a prescription diagnostic medication used to examine the eye. Manufacturer Nomax Inc initiated the recall because the active pharmaceutical ingredient does not meet current USP monograph specifications for unspecified impurities.
The recall affects 15,056 cartons distributed nationwide. Affected lot numbers are 14904 (100-strip carton, expiration 06/30/2024), 14938 (100-strip carton, expiration 07/31/2024), and 14931 (300-strip carton, expiration 06/30/2024).
The active pharmaceutical ingredient contains unspecified impurities that do not comply with manufacturing standards. Healthcare providers and patients should verify their product lot numbers and contact Nomax Inc or the FDA for additional information regarding the recall.
The recalled product
- Product
- GLOSTRIPS (FLUORESCEIN SODIUM)
- Brand
- GLOSTRIPS
- Manufacturer
- Nomax Inc
- Category
- Drug — Ophthalmic
- Hazard
- api-impurity
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 (5)
- Lot #s: a) 14904
- Exp. 06/30/2024
- Lot 14938
- Exp. 07/31/2024
- b) Lot 14931
Distribution
Distributed nationwide across the United States.
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