4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial a
Summary
The FDA issued a Class I for 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT U by Pfizer Inc.. Reason: Presence of Particulate Matter: identified as glass..
Details
Source
Drug Recall
External ID
D-0100-2024
Action Date
2023-11-15
Status
Terminated
Category
drug
Product Description
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
Lot/Code Info: Lot#: GJ5007, Exp. 8/1/2024
Quantity Affected: 24,900 vials
Reason for Recall
Presence of Particulate Matter: identified as glass.
Distribution
Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-02
Company
New York, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pfizer Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pfizer Inc. have FDA actions?
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0100-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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