FDA recall D-0749-2022

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.

Reason for recall

Labeling: Label Mix-Up

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-03-11

Report date

2022-04-13

Termination date

2023-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Upper Saddle River, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0749-2022