Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Tele
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Summary
The FDA issued a Class III for Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx onl by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy. Reason: Subpotent drug.
Details
Source
Drug Recall
External ID
D-0569-2022
Action Date
2022-03-02
Status
Terminated
Category
drug
Product Description
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392
Lot/Code Info: Lot #: Nore1620220111, Nore1620220113, Nore1620220118, Nore1620220125, Nore1620220127, Nore1620220202, Exp 3/31/22
Quantity Affected: 1157 bags
Reason for Recall
Subpotent drug
Distribution
Florida
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-14
Company
Temple Terrace, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 98 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy have FDA actions?
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0569-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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