Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) furthe
Summary
The FDA issued a Class I for Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glas by Pfizer Inc.. Reason: Presence of particulate matter: particulate identified as a beetle..
Details
Source
Drug Recall
External ID
D-1301-2022
Action Date
2022-08-03
Status
Terminated
Category
drug
Product Description
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Lot/Code Info: Lot #: DX9067, Exp 5/1/2023
Quantity Affected: 54,000 vials
Reason for Recall
Presence of particulate matter: particulate identified as a beetle.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-13
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 77 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-1301-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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