Product Safety Recalls

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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

Mandated?Voluntary: Firm initiated
Recall NumberD-0749-2022
Event ID89814
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
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