GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-
Summary
The FDA issued a Class III for GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition by HF Acquisition Co LLC. Reason: Labeling: Label Mix-up.
Details
Source
Drug Recall
External ID
D-0870-2023
Action Date
2023-06-14
Status
Terminated
Category
drug
Product Description
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Lot/Code Info: Lot #: 2205095.1, Exp. Date 7/31/2024
Quantity Affected: 9 boxes of 25 vials
Reason for Recall
Labeling: Label Mix-up
Distribution
Distributed in TX, AZ and CA only
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-06
Company
Mukilteo, WA
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 122 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
HF Acquisition Co LLC has 4 FDA actions in our database, including 4 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 (HF Acquisition Co LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HF Acquisition Co LLC have FDA actions?
HF Acquisition Co LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0870-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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