fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mc
Summary
The FDA issued a Class II for fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL I by SCA Pharmaceuticals, LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0398-2024
Action Date
2024-04-03
Status
Terminated
Category
drug
Product Description
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
Lot/Code Info: Lot #: 1223049754, Exp 01/12/24; 1223049992, Exp 01/23/24; 1223050066, Exp 01/25/24
Quantity Affected: 613 Cassettes
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-09
Company
Windsor, CT
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 69 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
SCA Pharmaceuticals, LLC has 32 FDA actions in our database, including 32 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 (SCA Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SCA Pharmaceuticals, LLC have FDA actions?
SCA Pharmaceuticals, LLC has 32 FDA actions in our database, including 32 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0398-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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