Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 5180
Check against the official notice below — it lists the full affected range.
Nomax Inc. is recalling Fluorescein Sodium Ophthalmic Strips USP (sold as Fluorescein GloStrips and Ful-Glo) because the product may not meet specifications for uniformity of dosage. The issue stems from packaging degradation in the paper pouch's adhesive component, which can affect the amount of fluorescein present in individual strips. The recall affects 23,201 cartons distributed nationwide in the United States and Puerto Rico, as well as internationally in Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia.
The recalled products include specific lot numbers with expiration dates ranging from November 2017 through May 2019. Affected lot numbers are GloStrips Lots 9031 (Exp 12/17), 9023 (Exp 11/17), 9065 (Exp 01/18), 9127 (Exp 03/18), and 9132 (Exp 03/18), as well as Ful-Glo Lots 9050 (Exp 12/18), 9113 (Exp 02/19), and 9206 (Exp 05/19). The source document does not specify what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia Quantity: 23,201 cartons Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.