FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL C
Summary
The FDA issued a Class II for FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag by SCA Pharmaceuticals. Reason: cGMP deviations: due to shipment of rejected units..
Details
Source
Drug Recall
External ID
D-0945-2023
Action Date
2023-08-02
Status
Terminated
Category
drug
Product Description
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Lot/Code Info: Lot # 1223047134, Use By: 09/21/2023
Quantity Affected: 183 bags
Reason for Recall
cGMP deviations: due to shipment of rejected units.
Distribution
KY and NJ
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-20
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 51 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
SCA Pharmaceuticals has 6 FDA actions in our database, including 6 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) 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 have FDA actions?
SCA Pharmaceuticals has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0945-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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