Nomax Recalls Fluorescein Sodium Ophthalmic Strips for Content Uniformity Issues
Nomax Inc is recalling Fluorescein Sodium Ophthalmic Strips because packaging degradation may affect dosage uniformity. The recall covers 62,691 cartons distributed in the US and internationally.
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 indicates the product is unlikely to cause adverse health consequences. The issue is a packaging degradation affecting content uniformity, with no reported injuries or illnesses.
Plain-English summary
Nomax Inc is recalling Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, under the brand names FUL-GLO and Fluorescein Pro Glo Strips. The recall involves 62,691 cartons of the product. The affected lots include FUL-GLO lots 8980, 9081, 9088, 9128, and 9158, as well as Pro Glo lot 9082.
The recall was initiated because the product may not meet finished product release specifications, specifically regarding the uniformity of dosage. This issue is attributed to packaging degradation related to the adhesive component of the paper pouch, which can impact the level of fluorescein present in the strips.
The product was distributed nationwide and in Puerto Rico, as well as in Australia, Brazil, Canada, Chile, Colombia, the Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia. Consumers should check their inventory for the specific lot numbers and expiration dates listed above and stop using the product if it matches the recalled items.
The recalled product
- Product
- Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), UPC 3 17478 40401 9, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.; and
- Manufacturer
- Nomax Inc
- Category
- Drug — Ophthalmic
- Affected units
- 62,691
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 (10)
- 1) FUL-GLO Lot: 8980
- Exp 10/15
- 9081
- Exp 01/16
- 9088
- Exp 02/16
- 9128 and 9158
- Exp 03/16
- 2) Pro Glo Lot: 9082
- Exp 01/17
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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