VANCOMYCIN HYDROCHLORIDE Recall D-0184-2023
Description: Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
VANCOMYCIN HYDROCHLORIDE Recall D-0184-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0184-2023 |
| Event ID | 91346 |
| Brand | VANCOMYCIN HYDROCHLORIDE |
| Generic Name | VANCOMYCIN HYDROCHLORIDE |
| Manufacturer | VANCOMYCIN HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | VANCOMYCIN HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide and Puerto Rico |
| Quantity | 89,700 vials |
| Recall Reason | Presence of Particulate Matter: Glass particulate matter detected in injectable. |
| Drug Classification | Class I |
| Drug Code Info | 20230201 |
| Product NDC | 0409-3515 0409-6531 0409-6533 |
| Recall Initiation Date | 20221222 |
| Report Date | 20230201 |
| Classification Date | 20230125 |
| Address | 235 East 42nd Street New York, NY 10017-5703 United States |
| Recalling Firm | Pfizer Inc. |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 71WO621TJD |
| Drug Application Number | ANDA062912 |
| Structured Product Labeling (SPL ID) | 552b107c-a0fd-47e6-93f8-67bafdcfbc27 |
| Structured Product Labeling (SPL Set ID) | f2901045-904f-47bd-74a1-c561facd7f25 |
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