Product Safety Recalls

Product Recall Tracker

WATER Recall D-1315-2022

Description: Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.

WATER Recall D-1315-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1315-2022
Event ID90553
BrandEYE STREAM
Generic NamePURIFIED WATER
ManufacturerPURIFIED WATER
Original Package?1
Active SubstanceWATER
Drug RouteOPHTHALMIC
DistributionNationwide in the USA.
Quantity16 boxes
Recall ReasonCGMP Deviations: products were stored outside the drug label specifications.
Drug ClassificationClass II
Drug Code Info20220817
Product NDC0065-0530
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 Identifier059QF0KO0R
Drug Application Numberpart349
Structured Product Labeling (SPL ID)b61b61a6-aea9-463b-90ca-c683fea1104c
Structured Product Labeling (SPL Set ID)ff9560df-d834-57a8-37b0-3f10e82f5a5d
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