Bio Glo fluorescein strips 300-count recalled over sterility assurance failure
Wizcure Pharmaa is recalling all lots of Bio Glo Fluorescein Sodium Ophthalmic Strips in 300-strip packs because the products were not manufactured in conformance with current good manufacturing practices.
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 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a sterile ophthalmic diagnostic product whose sterility cannot be assured, with no injuries stated in the source.
Plain-English summary
Wizcure Pharmaa Private Limited is recalling Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, NDC 17238-900-30. The product is manufactured by Omni Lens Pvt. Ltd. of Ahmedabad, India, for HUB Pharmaceuticals, LLC of Scottsdale, Arizona. About 50,400 boxes were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for lack of assurance of sterility: the products have not been manufactured in conformance with current good manufacturing practices.
All lots are affected.
Clinicians can identify affected product by the NDC number above, and may contact Wizcure Pharmaa Private Limited for further information.
The recalled product
- Product
- Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:[email protected], Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de…
- Manufacturer
- Wizcure Pharmaa Private Limited
- Category
- Drug — Ophthalmic diagnostic
- Affected units
- 50,400
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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