FDA (Drugs) recall action 70552
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Nomax Inc. is recalling GLOSTRIPS and FUL-GLO ophthalmic strips because packaging degradation may affect dosage uniformity. No illnesses have been reported.
Nomax Inc. is recalling GLOSTRIPS ophthalmic strips because packaging degradation may affect the uniformity of the rose bengal dosage.
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.