Nomax Recalls GLOSTRIPS Ophthalmic Strips for Packaging Degradation
Nomax Inc. is recalling GLOSTRIPS ophthalmic strips because packaging degradation may affect the uniformity of the rose bengal dosage.
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 dosage uniformity, with no reported injuries or illnesses.
Plain-English summary
Nomax Inc. is recalling GLOSTRIPS (Rose Bengal Sodium) Ophthalmic Strips. The recall involves 5,514 cartons of the product, which is distributed nationwide and in several international locations including Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, the Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia. The affected lots are 8925 (Exp 07/17), 8972 (Exp 10/17), and 9195 (Exp 04/18).
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 rose bengal present in the strips.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the supplier or the manufacturer for disposal or credit, in accordance with standard recall procedures.
The recalled product
- Product
- GLOSTRIPS (ROSE BENGAL SODIUM)
- Brand
- GLOSTRIPS
- Manufacturer
- Nomax Inc
- Category
- Drug — Ophthalmic
- Affected units
- 5,514
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 (6)
- Lot #: 8925
- Exp 07/17
- 8972
- Exp 10/17
- and 9195
- Exp 04/18
UPCs (1)
- 351801004408
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.
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