FDAFDA · Food and drugs·Recall number D-0962-2015
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 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA.
Published April 29, 2015 · Recall initiated: March 24, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GLOSTRIPS
- Manufacturer
- Nomax Inc
- Distributor
- Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
- UPC
- 351801004408
- Lot
- Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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