Product Safety Recalls

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POLYETHYLENE GLYCOL 3350 Recall D-0875-2022

Description: GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

POLYETHYLENE GLYCOL 3350 Recall D-0875-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0875-2022
Event ID90094
BrandGAVILYTE - C
Generic NamePOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK
ManufacturerPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK
Original Package?1
Active SubstancePOLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE
Drug RouteORAL
DistributionProduct was distributed nationwide, including Puerto Rico.
Quantity26,910 bottles
Recall ReasonFailed Stability Specification
Drug ClassificationClass II
Drug Code Info20220525
Product NDC43386-060
Product NUIN0000010288 N0000175811 N0000009871
Drug UPC0343386060191 0343386204021
Pharma Class (PE)Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Pharma Class (EPC)Osmotic Laxative [EPC]
Recall Initiation Date20220427
Report Date20220525
Classification Date20220516
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierG2M7P15E5P 660YQ98I10
Drug Application NumberANDA090186
Structured Product Labeling (SPL ID)7af81acb-3c86-4089-93dc-2cf9a6fac42a
Structured Product Labeling (SPL Set ID)a8b15625-ca7c-4d57-9f36-3ac2a6d13665
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