Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
Summary
The FDA issued a Class II for Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceutic by SCA Pharmaceuticals. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0829-2022
Action Date
2022-05-11
Status
Terminated
Category
drug
Product Description
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
Lot/Code Info: Lot #: 1222035815, Exp. Date 10-Jul-22
Quantity Affected: 120 bags
Reason for Recall
CGMP Deviations
Distribution
Product was distributed nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-25
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 81 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-0829-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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