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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1496-2022 |
Event ID | 90813 |
Brand | SODIUM CHLORIDE |
Generic Name | SODIUM CHLORIDE |
Manufacturer | SODIUM CHLORIDE |
Original Package? | 1 |
Active Substance | SODIUM CHLORIDE |
Drug Route | OPHTHALMIC |
Distribution | USA nationwide |
Quantity | 48,636 tubes |
Recall Reason | cGMP 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 Classification | Class II |
Drug Code Info | 20220914 |
Product NDC | 17478-622 |
Drug UPC | 0317478622352 |
Recall Initiation Date | 20220831 |
Report Date | 20220914 |
Classification Date | 20220906 |
Address | 5605 Centerpoint Ct Ste A Gurnee, IL 60031-5278 United States |
Recalling Firm | Akorn, Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | 451W47IQ8X |
Drug Application Number | part349 |
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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