Product Safety Recalls

Product Recall Tracker

WATER Recall D-0364-2023

Description: Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01

WATER Recall D-0364-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0364-2023
Event ID91767
BrandSTERILE WATER
Generic NameSTERILE WATER
ManufacturerSTERILE WATER
Original Package?1
Active SubstanceWATER
Drug RouteINTRAMUSCULAR
DistributionUnited States
Quantity325,080 vials
Recall ReasonCGMP Deviations: Potential product carryover.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC0487-6105
Recall Initiation Date20230223
Report Date20230308
Classification Date20230301
Address4500 12th Street Ext
West Columbia, SC 29172-3025
United States
Recalling FirmNephron Sc Inc
Initial Notification Letter
Unique Ingredient Identifier059QF0KO0R
Drug Application NumberANDA211222
Structured Product Labeling (SPL ID)c3f4ecb1-53e1-5894-e053-2995a90ade2e
Structured Product Labeling (SPL Set ID)bc04a883-babc-87a6-e053-2995a90a3dfd
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