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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