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SODIUM CHLORIDE Recall D-1496-2022

Description: Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

SODIUM CHLORIDE Recall D-1496-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1496-2022
Event ID90813
BrandSODIUM CHLORIDE
Generic NameSODIUM CHLORIDE
ManufacturerSODIUM CHLORIDE
Original Package?1
Active SubstanceSODIUM CHLORIDE
Drug RouteOPHTHALMIC
DistributionUSA nationwide
Quantity48,636 tubes
Recall ReasoncGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Drug ClassificationClass II
Drug Code Info20220914
Product NDC17478-622
Drug UPC0317478622352
Recall Initiation Date20220831
Report Date20220914
Classification Date20220906
Address5605 Centerpoint Ct Ste A
Gurnee, IL 60031-5278
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient Identifier451W47IQ8X
Drug Application Numberpart349
Structured Product Labeling (SPL ID)cd581639-c1fb-4d6a-aefe-4723251dec9e
Structured Product Labeling (SPL Set ID)e00f4d11-0999-452a-87bb-4d477db294a6
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