DASH Pharmaceuticals LLC recalls Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 c…

Recall date

March 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0749-2022

FDA classification

Class II

Brand / firm

DASH Pharmaceuticals LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

Labeling: Label Mix-Up

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.