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

FDA recall notice · announced April 29, 2015 · Nomax

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

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.

Notes

Distribution: Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Lot/code information: Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18
Quantity: 5,514 cartons
Status: Terminated
Products in this recall event:
- 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 str (D-0961-2015)
- Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped strips, barcode (01)00317478404019; packaged in 100-count strips per carton, (NDC 17478-404-01), (D-0963-2015)
- 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 518 (D-0962-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.