Meitheal Pharmaceuticals Glycopyrrolate Injection Recall

Why it was recalled

Failed Impurities/Degradation Specifications

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 numbers, UPCs & expiration codes

Lot #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023

Where it was sold

Nationwide within the USA and India

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0801-2021
Classification: Class III
Status: Terminated
Recall initiated: Sep 3, 2021
FDA report date: Sep 22, 2021
Quantity: 1,160 ten-pack cartons
Recall type: Voluntary: Firm initiated
Recalling firm: Meitheal Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0801-2021, exactly as published.

Show all FDA fields

City: Chicago
State: IL
Status: Terminated
Country: United States
Event ID: 88619
Address: 8700 W Bryn Mawr Ave Ste 600
Code information: Lot #: G0010120, Exp. Date December 2021; G0080520, Exp. Date April 2022; G0090221, G0100221, Exp. Date January 2023
Postal code: 60631-3512
Report date: Sep 22, 2021
Product type: Drugs
Recall number: D-0801-2021
Classification: Class III
Recalling firm: Meitheal Pharmaceuticals Inc
Product quantity: 1,160 ten-pack cartons
Termination date: May 12, 2024
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: Nationwide within the USA and India
Recall initiation date: Sep 3, 2021
Initial firm notification: Letter
Center classification date: Sep 15, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0801-2021, published Sep 22, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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