AMPICILLIN SODIUM Recall D-1009-2022
Description: Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10
AMPICILLIN SODIUM Recall D-1009-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1009-2022 |
| Event ID | 89646 |
| Brand | AMPICILLIN |
| Generic Name | AMPICILLIN SODIUM |
| Manufacturer | AMPICILLIN SODIUM |
| Original Package? | 1 |
| Active Substance | AMPICILLIN SODIUM |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA nationwide. |
| Quantity | 10 cartons/10 vials each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 55150-111 55150-112 55150-113 |
| Drug UPC | 0355150112104 0355150113101 0355150111107 |
| 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 | JFN36L5S8K |
| Drug Application Number | ANDA065499 |
| Structured Product Labeling (SPL ID) | 768505cc-508a-40e1-a6d8-eacf9d60b907 |
| Structured Product Labeling (SPL Set ID) | b7bf2897-8272-4c7d-84e9-6fbba0ea63fa |
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