Drug 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.
D-0962-2015
Product summary
- Firm
- Nomax Inc
- Event
- Event 70552
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,514 cartons
- Official record key
drug-enforcement:D-0962-2015
Official wording
Reason: 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.
Code information: Lot #: 8925, Exp 07/17; 8972, Exp 10/17; and 9195, Exp 04/18
Distribution pattern: Nationwide and Puerto Rico, Australia, Brazil, Canada, Chile, Colombia, Dominican Republic, Honduras, Iceland, Israel, Jamaica, Trinidad and Tobago, and St. Lucia
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications