BACITRACIN ZINC Recall D-0132-2023
Description: AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
BACITRACIN ZINC Recall D-0132-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0132-2023 |
| Event ID | 90948 |
| Brand | AK-POLY-BAC |
| Generic Name | BACITRACIN ZINC AND POLYMYXIN B SULFATE |
| Manufacturer | BACITRACIN ZINC AND POLYMYXIN B SULFATE |
| Original Package? | 1 |
| Active Substance | BACITRACIN ZINC POLYMYXIN B SULFATE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide in the USA |
| Quantity | 36,025 tubes |
| Recall Reason | CGMP Deviations: |
| Drug Classification | Class II |
| Drug Code Info | 20230125 |
| Product NDC | 17478-238 |
| Drug UPC | 0317478238355 |
| 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 | 89Y4M234ES 19371312D4 |
| Drug Application Number | ANDA064028 |
| Structured Product Labeling (SPL ID) | f764e0be-a828-4f44-9c91-86326a152f48 |
| Structured Product Labeling (SPL Set ID) | 8b750666-18f2-40f5-9fb3-87457001b485 |
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