D-0962-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 29, 2015
- Initiation Date
- March 24, 2015
- Termination Date
- February 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,514 cartons
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Code Information
Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18