Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago,
Summary
The FDA issued a Class III for Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd by Meitheal Pharmaceuticals Inc. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0801-2021
Action Date
2021-09-22
Status
Terminated
Category
drug
Product Description
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
Lot/Code Info: Lot #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023
Quantity Affected: 1,160 ten-pack cartons
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the USA and India
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-03
Company
Chicago, IL
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 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Meitheal Pharmaceuticals Inc has 2 FDA actions in our database, including 2 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 (Meitheal Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Meitheal Pharmaceuticals Inc have FDA actions?
Meitheal Pharmaceuticals Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0801-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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