Nomax Recalls Fluorescein Sodium Ophthalmic Strips for Packaging Degradation
Nomax Inc. is recalling GLOSTRIPS and FUL-GLO ophthalmic strips because packaging degradation may affect dosage uniformity. No illnesses have been reported.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a packaging degradation affecting dosage uniformity, with no reported illnesses.
Plain-English summary
Nomax Inc. is voluntarily recalling specific lots of GLOSTRIPS (Fluorescein Sodium) and FUL-GLO ophthalmic strips. The recall is due to a packaging degradation related to the adhesive component of the paper pouch, which may impact the level of fluorescein present in the strips and cause the product to fail content uniformity specifications.
The affected products include GLOSTRIPS (NDC 51801-003-01, 51801-003-40, and 51801-003-50) and FUL-GLO (NDC 17478-403-03). Specific lot numbers and expiration dates are listed in the recall notice. The products were distributed nationwide, in Puerto Rico, and in several international locations including Australia, Brazil, Canada, Chile, Colombia, the Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. No illnesses or injuries have been reported. Consumers and healthcare providers should stop using the affected lots and contact their supplier or Nomax Inc. for instructions on return or replacement.
The recalled product
- Product
- GLOSTRIPS (FLUORESCEIN SODIUM)
- Brand
- GLOSTRIPS
- Manufacturer
- Nomax Inc
- Category
- Drug — Ophthalmic
- Affected units
- 23,201
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 (14)
- 1) GloStrips Lot: a) 9031
- Exp 12/17
- b) 9023
- Exp 11/17
- 9065
- Exp 01/18
- 9127 and 9132
- Exp 03/18
- and 2) Ful-Glo Lot: 9050
- Exp 12/18
- 9113
- Exp 02/19
- and 9206
- Exp 05/19
UPCs (3)
- 351801003401
- 351801003500
- 317478403036
Distribution
Part of a larger recall action
This product is one of 3 recalled by Nomax Inc 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.
See all 3 products in this recall →Related recalls
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