Product Safety Recalls

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POLYETHYLENE GLYCOL 400 Recall D-1314-2022

Description: Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.

POLYETHYLENE GLYCOL 400 Recall D-1314-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1314-2022
Event ID90553
BrandSYSTANE LUBRICANT
Generic NamePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL
ManufacturerPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL
Original Package?1
Active SubstancePOLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL
Drug RouteOPHTHALMIC
DistributionNationwide in the USA.
Quantity47 bottles
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0065-0429
Recall Initiation Date20220629
Report Date20220817
Classification Date20220805
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierB697894SGQ 6DC9Q167V3
Drug Application Numberpart349
Structured Product Labeling (SPL ID)da3602aa-464a-48f0-b271-bb8a92510976
Structured Product Labeling (SPL Set ID)15bc06ec-f3dc-3180-ca1a-106769a770ea
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