Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only,
Summary
The FDA issued a Class II for Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% by Apollo Care. Reason: Lack of assurance of sterility: Suspected microbial growth present on external label packaging..
Details
Source
Drug Recall
External ID
D-0487-2023
Action Date
2023-04-05
Status
Ongoing
Category
drug
Product Description
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Lot/Code Info: Lot #: AC-016581
Quantity Affected: 215 bags
Reason for Recall
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Distribution
MO
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-08
Company
Columbia, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 34 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apollo Care has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Apollo Care) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apollo Care have FDA actions?
Apollo Care has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0487-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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