Product Safety Recalls

Product Recall Tracker

SUCRALFATE Recall D-0749-2022

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.

SUCRALFATE Recall D-0749-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0749-2022
Event ID89814
BrandSUCRALFATE
Generic NameSUCRALFATE
ManufacturerSUCRALFATE
Original Package?1
Active SubstanceSUCRALFATE
Drug RouteORAL
DistributionNationwide within the United States
Quantity45,940 Unit Dose Cups
Recall ReasonLabeling: Label Mix-Up
Drug ClassificationClass II
Drug Code Info20220413
Product NDC69339-148
Product NUIN0000175801 M0015420
Pharma Class (EPC)Aluminum Complex [EPC]
Pharma Class (CS)Organometallic Compounds [CS]
Recall Initiation Date20220311
Report Date20220413
Classification Date20220406
Address2 Park Way
Upper Saddle River, NJ 07458-2345
United States
Recalling FirmDASH Pharmaceuticals LLC
Initial Notification Letter
Unique Ingredient IdentifierXX73205DH5
Drug Application NumberNDA019183
Structured Product Labeling (SPL ID)3d0de6fb-6d76-4ad8-8cb6-cabd6d4513f0
Structured Product Labeling (SPL Set ID)c76c7bcb-d481-43ff-809b-da8e0e88f096
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.