Product Safety Recalls

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ERYTHROMYCIN Recall D-0138-2023

Description: ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35

ERYTHROMYCIN Recall D-0138-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0138-2023
Event ID90948
BrandERYTHROMYCIN
Generic NameERYTHROMYCIN
ManufacturerERYTHROMYCIN
Original Package?1
Active SubstanceERYTHROMYCIN
Drug RouteOPHTHALMIC
DistributionNationwide in the USA
Quantity1,109,600 tubes
Recall ReasonCGMP Deviations:
Drug ClassificationClass II
Drug Code Info20230125
Product NDC17478-070
Product NUIN0000009982 N0000175877 N0000175935
Drug UPC0317478070351
Pharma Class (PE)Decreased Sebaceous Gland Activity [PE]
Pharma Class (EPC)Macrolide [EPC]
Pharma Class (CS)Macrolides [CS]
Recall Initiation Date20221013
Report Date20230125
Classification Date20230113
Address5605 Centerpoint Ct Ste A
Gurnee, IL 60031-5278
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient Identifier63937KV33D
Drug Application NumberANDA064030
Structured Product Labeling (SPL ID)6d8d9148-981f-4930-8d60-95ab92ce4e1f
Structured Product Labeling (SPL Set ID)a0353c10-48c9-4d2a-8047-56ea68ace956
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