Product Safety Recalls

Product Recall Tracker

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Recall D-0717-2022

Description: TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Recall D-0717-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0717-2022
Event ID89836
BrandTHERATEARS EXTRA
Generic NameCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
ManufacturerCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
Original Package?1
Active SubstanceCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
Drug RouteOPHTHALMIC
DistributionNationwide within theUSA
Quantity62,331 box
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20220330
Product NDC58790-010
Recall Initiation Date20210908
Report Date20220330
Classification Date20220324
Address1925 W Field Ct Ste 300
Lake Forest, IL 60045-4862
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient IdentifierK679OBS311
Drug Application Numberpart349
Structured Product Labeling (SPL ID)735d60b9-9999-4e46-827c-abf2a2b70401
Structured Product Labeling (SPL Set ID)f1845041-9d8d-42a0-a2cb-68def7a5aac7
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.