Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding
Summary
The FDA issued a Class III for Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Un by Denver Solutions, LLC DBA Leiters Health. Reason: Labeling: Not Elsewhere Classified.
Details
Source
Drug Recall
External ID
D-0070-2024
Action Date
2023-11-01
Status
Terminated
Category
drug
Product Description
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70
Lot/Code Info: Lot#: 2330956, Exp. 10/23/2023; 2330964, Exp. 10/24/2023; 2331014, Exp. 11/6/2023; 2331033, Exp. 11/8/2023
Quantity Affected: 6,276 IV bags
Reason for Recall
Labeling: Not Elsewhere Classified
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-04
Company
Englewood, CO
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 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Denver Solutions, LLC DBA Leiters Health has 22 FDA actions in our database, including 22 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 (Denver Solutions, LLC DBA Leiters Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Denver Solutions, LLC DBA Leiters Health have FDA actions?
Denver Solutions, LLC DBA Leiters Health has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0070-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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