FDA Drug Class II — Moderate

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.

Hazard

Labeling: Label Mix-Up

Products

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, Upp
Brand
DASH Pharmaceuticals LLC
UPC
Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023

Units Affected

45,940 Unit Dose Cups