Fluorescein Sodium Ophthalmic Strips Recalled Over Sterility Concerns
Wizcure Pharmaa is recalling all lots of Fluorescein Sodium Ophthalmic Strips because the products may not have been manufactured according to current good manufacturing practices, raising concerns about sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterility assurance issue for an ophthalmic drug product. The lack of sterility assurance for a product applied to the eye poses a risk of infection or other harm, which falls under the rubric criterion for FDA Class II recalls with potential for significant injury.
Plain-English summary
Wizcure Pharmaa Private Limited is recalling all lots of C20H10NA2O5 Fluorescein Sodium Ophthalmic Strips, USP 1mg. The product is packaged as a 100-count box (NDC 83851-100-10) and a 300-count box (NDC 83851-100-30), with a total of 10,080 boxes involved in the recall.
The recall is being issued due to a lack of assurance of sterility. According to the recall notice, the products have not been manufactured in conformance with current good manufacturing practices, which raises concerns about whether the sterility of the ophthalmic strips product can be assured.
The recalled product was distributed nationwide in the USA. Healthcare professionals and consumers who have the affected product should stop using it immediately and return any remaining product to the place of purchase for a full refund.
The recall affects all lots of the product. No specific lot numbers are listed because the recall applies to every unit produced. Consumers with questions can contact the recalling firm, Wizcure Pharmaa Private Limited.
The recalled product
- Product
- C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM)
- Brand
- C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS
- Manufacturer
- Wizcure Pharmaa Private Limited
- Category
- Drug — Ophthalmic Strips
- Affected units
- 10,080
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Wizcure Pharmaa Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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