AMPICILLIN SODIUM Recall D-1542-2022
Description: Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
AMPICILLIN SODIUM Recall D-1542-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1542-2022 |
| Event ID | 90886 |
| Brand | AMPICILLIN |
| Generic Name | AMPICILLIN |
| Manufacturer | AMPICILLIN |
| Original Package? | 1 |
| Active Substance | AMPICILLIN SODIUM |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide in the USA |
| Quantity | 3,931 cartons |
| Recall Reason | Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial. |
| Drug Classification | Class II |
| Drug Code Info | 20221005 |
| Product NDC | 67457-351 67457-353 67457-350 |
| Drug UPC | 0367457353104 0367457350103 0367457351100 |
| Recall Initiation Date | 20220921 |
| Report Date | 20221005 |
| Classification Date | 20220923 |
| Address | 1000 Mylan Blvd Canonsburg, PA 15317-5853 United States |
| Recalling Firm | Viatris Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | JFN36L5S8K |
| Drug Application Number | ANDA201025 |
| Structured Product Labeling (SPL ID) | 43d50ba5-a7ba-464e-a6fa-deca84dfb670 |
| Structured Product Labeling (SPL Set ID) | f1ee20ce-df0a-4a30-af90-8ea9577b4814 |
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