RecallDepth
Class III Terminated

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.

Company
Nomax Inc
Recall Initiated
March 24, 2015
Posted
April 29, 2015
Recall Number
D-0962-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
5,514 cartons
Firm Location
Saint Louis, MO, United States

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

Lot / Code Info

Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18

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