fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CA
Summary
The FDA issued a Class II for fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 by QuVa Pharma, Inc.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0296-2025
Action Date
2025-04-02
Status
Ongoing
Category
drug
Product Description
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
Lot/Code Info: Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025
Quantity Affected: 2,310 cassettes
Reason for Recall
Lack of Assurance of Sterility
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-06
Company
Sugar Land, TX
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 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
QuVa Pharma, Inc. has 5 FDA actions in our database, including 5 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 (QuVa Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does QuVa Pharma, Inc. have FDA actions?
QuVa Pharma, Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0296-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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