FDA Recall Quelicin
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on June 15th, 2017 and classified as a Class II recall due to lack of sterility assurance This recall is currently terminated, and the associated recall number is recall number is D-1048-2017. It pertains to Quelicin identified by 0409-6629 as of 07-20-2020 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-1048-2017 | 06-15-2017 | 08-09-2017 | 15,034,600 10 mL multiple dose use vials | Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25). | Lack of Sterility Assurance | Terminated |
| D-0836-2016 | 03-15-2016 | 05-11-2016 | 103,600 vials | Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02 | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial. | Ongoing |
| D-315-2013 | 02-26-2013 | 05-15-2013 | 139,200 vials | QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | 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.
