Drug product
Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
D-0749-2022
Product summary
- Event
- Event 89814
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,940 Unit Dose Cups
- Official record key
drug-enforcement:D-0749-2022
Official wording
Reason: Labeling: Label Mix-Up
Code information: Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up