Product Safety Recalls

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ALUMINUM HYDROXIDE Recall D-0868-2022

Description: Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

ALUMINUM HYDROXIDE Recall D-0868-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0868-2022
Event ID89879
BrandMAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE
Generic NameMAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE
ManufacturerMAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE
Original Package?1
Active SubstanceALUMINUM HYDROXIDE DIMETHICONE
Drug RouteORAL
DistributionDistributed in Indiana for further distribution in the USA.
Quantity23,300 Unit Dose cups
Recall ReasonMicrobial Contamination of Non-Sterile Products
Drug ClassificationClass I
Drug Code Info20220525
Product NDC0904-6838 0904-6839
Product NUIN0000010282
Drug UPC0309046839736 0309046838739
Pharma Class (PE)Skin Barrier Activity [PE]
Recall Initiation Date20220324
Report Date20220525
Classification Date20220513
Address3780 Greenway Cir
Lawrence, KS 66046-5440
United States
Recalling FirmPlastikon Healthcare LLC
Initial Notification Press Release
Unique Ingredient Identifier92RU3N3Y1O 5QB0T2IUN0
Drug Application Numberpart331
Structured Product Labeling (SPL ID)d35bc479-bb6f-c173-e053-2995a90a3e62
Structured Product Labeling (SPL Set ID)97978a75-bf85-ba66-e053-2995a90a3b2d
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