AZITHROMYCIN MONOHYDRATE Recall D-0997-2022
Description: Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10
AZITHROMYCIN MONOHYDRATE Recall D-0997-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0997-2022 |
| Event ID | 89646 |
| Brand | AZITHROMYCIN |
| Generic Name | AZITHROMYCIN |
| Manufacturer | AZITHROMYCIN |
| Original Package? | 1 |
| Active Substance | AZITHROMYCIN MONOHYDRATE |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | 13 carton/10 vials each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 55150-174 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | JTE4MNN1MD |
| Drug Application Number | ANDA203294 |
| Structured Product Labeling (SPL ID) | 87cd6c86-6488-441b-aa9c-5811fbc5771e |
| Structured Product Labeling (SPL Set ID) | 7b81436e-d14a-4353-a22d-253f45e2e576 |
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