FDA-Drug2022-04-13Class II

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.

DASH Pharmaceuticals LLC
Hazard

Labeling: Label Mix-Up

Sold states
Nationwide within the United States
Affected count
45,940 Unit Dose Cups
Manufactured in
2 Park Way, Upper Saddle River, NJ, United States
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, Upper Saddle River, NJ 07458.

Official notice

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

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