PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: April 13, 2022 Initiated: March 11, 2022 #D-0749-2022

Product Description

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

Details

Recalling Firm
DASH Pharmaceuticals LLC
Units Affected
45,940 Unit Dose Cups
Distribution
Nationwide within the United States
Location
Upper Saddle River, NJ

Frequently Asked Questions

What product 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.. Recalled by DASH Pharmaceuticals LLC. Units affected: 45,940 Unit Dose Cups.
Why was this product recalled?
Labeling: Label Mix-Up
Which agency issued this recall?
This recall was issued by the FDA Drug on April 13, 2022. Severity: Moderate. Recall number: D-0749-2022.