Product Safety Recalls

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DEXTROMETHORPHAN HYDROBROMIDE Recall D-0787-2022

Description: Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.

DEXTROMETHORPHAN HYDROBROMIDE Recall D-0787-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0787-2022
Event ID89905
BrandWAL-TUSSIN DM
Generic NameDEXTROMETHORPHAN HBR, GUAIFENESIN
ManufacturerDEXTROMETHORPHAN HBR, GUAIFENESIN
Original Package?1
Active SubstanceDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN
Drug RouteORAL
DistributionIL only
Quantity117,552 units
Recall ReasonIncorrect/Undeclared Excipient: Product contains alcohol
Drug ClassificationClass III
Drug Code Info20220504
Product NDC0363-0324
Product NUIN0000193956 N0000008867 N0000009560
Pharma Class (PE)Decreased Respiratory Secretion Viscosity [PE]
Pharma Class (EPC)Expectorant [EPC]
Recall Initiation Date20220329
Report Date20220504
Classification Date20220425
Address1533 Union Ave
Pennsauken, NJ 08110-2489
United States
Recalling FirmAptaPharma Inc.
Initial Notification Letter
Unique Ingredient Identifier9D2RTI9KYH 495W7451VQ
Drug Application Numberpart341
Structured Product Labeling (SPL ID)ae894d3e-edb5-4a67-bedd-76f9f7905be0
Structured Product Labeling (SPL Set ID)054b44e8-0226-4cbd-a113-13da0ac90f05
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