Drug recall D-0962-2015
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.
Lots and codes
Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18
Recall details
- Recalling firm
- Nomax Inc, Saint Louis, MO
- Quantity
- 5,514 cartons
- Distribution
- Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 24, 2015
- Terminated
- February 21, 2017
Related products
- GloStrips – drug information
- NDC 51801-004 GloStrips · Rose Bengal Sodium 1.3 mg/1 · Nomax Inc.