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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0138-2023 |
Event ID | 90948 |
Brand | ERYTHROMYCIN |
Generic Name | ERYTHROMYCIN |
Manufacturer | ERYTHROMYCIN |
Original Package? | 1 |
Active Substance | ERYTHROMYCIN |
Drug Route | OPHTHALMIC |
Distribution | Nationwide in the USA |
Quantity | 1,109,600 tubes |
Recall Reason | CGMP Deviations: |
Drug Classification | Class II |
Drug Code Info | 20230125 |
Product NDC | 17478-070 |
Product NUI | N0000009982 N0000175877 N0000175935 |
Drug UPC | 0317478070351 |
Pharma Class (PE) | Decreased Sebaceous Gland Activity [PE] |
Pharma Class (EPC) | Macrolide [EPC] |
Pharma Class (CS) | Macrolides [CS] |
Recall Initiation Date | 20221013 |
Report Date | 20230125 |
Classification Date | 20230113 |
Address | 5605 Centerpoint Ct Ste A Gurnee, IL 60031-5278 United States |
Recalling Firm | Akorn, Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | 63937KV33D |
Drug Application Number | ANDA064030 |
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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