Nomax Inc recalls Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-0
Recalled April 29, 2015 · FDA recall D-0962-2015 · Nomax
Hazard
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. · FDA Class III
Units
5,514 cartons
Sold at
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Description
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.
Product
Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA.
Manufacturer(s)
Nomax Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →