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CALCIUM CHLORIDE Recall D-1033-2022

Description: BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15

CALCIUM CHLORIDE Recall D-1033-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1033-2022
Event ID89646
BrandBSS
Generic NameBALANCED SALT SOLUTION
ManufacturerBALANCED SALT SOLUTION
Original Package?1
Active SubstanceCALCIUM CHLORIDE MAGNESIUM CHLORIDE
Drug RouteOPHTHALMIC
DistributionUSA nationwide.
Quantity13 bottles
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0065-0795
Drug UPC0300650795159
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierM4I0D6VV5M 02F3473H9O
Drug Application NumberNDA020742
Structured Product Labeling (SPL ID)82defe39-5cf0-4928-acaa-2a597a1c9641
Structured Product Labeling (SPL Set ID)4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea
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