FDA Recall Vancomycin Hydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on December 22nd, 2022 and classified as a Class I recall due to presence of particulate matter: glass particulate matter detected in injectable. This recall is currently terminated, and the associated recall number is recall number is D-0184-2023. It pertains to Vancomycin Hydrochloride identified by 0409-6531 as of 08-07-2024 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0184-2023 | 12-22-2022 | 02-01-2023 | 89,700 vials | 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 | Presence of Particulate Matter: Glass particulate matter detected in injectable. | Terminated |
| D-0123-2018 | 08-30-2017 | 12-27-2017 | 102,500 vials | Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02 | Presence of Particulate Matter: glass particulate found in vial | Terminated |
| D-0254-2015 | 11-07-2014 | 11-26-2014 | 316,640 vials | Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01. | Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product. | Terminated |
| D-0387-2015 | 10-06-2014 | 02-25-2015 | 200 vials | Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01. | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Terminated |
| D-0390-2015 | 10-06-2014 | 02-25-2015 | 90,600 vials | Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01. | Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
