Nomax Inc: 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 cart

Is my product affected?

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.

• Brand GLOSTRIPS

Check against the official notice below — it lists the full affected range.

What happened

Nomax Inc is recalling Rose Bengal GloStrips, ophthalmic strips containing 1.3 mg of rose bengal per strip, because the product may not meet content uniformity specifications. The issue stems from packaging degradation of the adhesive component in the paper pouch, which can affect the amount of rose bengal present in the strips. The affected product is NDC 51801-004-01, packaged in 100-count cartons, with lot numbers 8925 (expiration 07/17), 8972 (expiration 10/17), and 9195 (expiration 04/18). Approximately 5,514 cartons were distributed nationwide and internationally to Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia.

The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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 rose bengal 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: 5,514 cartons Lot/code info: Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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