Glycopyrrolate Recall

Share Facebook icon Twitter icon Linkedin icon

September 02, 2021 

Dear Valued Customer: 

This letter is to inform you that Meitheal Pharmaceuticals, Inc. (“Meitheal”) is voluntarily recalling the following product:

This recall is being made with the knowledge of the Food and Drug Administration. Meitheal Pharmaceuticals, Inc. (Meitheal) announced the voluntary nationwide recall of four (4) lots of Glycopyrrolate Injection, USP 4mg per 20mL. This product was manufactured by Caplin Steriles Limited and distributed by Meitheal Pharmaceuticals, Inc. Meitheal has initiated this recall of Glycopyrrolate Injection, USP 4mg per 20mL because of an out of specification result observed for Benzaldehyde content during routine quality testing of stability samples at 18-month timepoint for Glycopyrrolate Injection, USP 4mg per 20mL Lot G0010120.


Benzaldehyde is an aromatic compound and can impact several organs like the brain, liver and kidney. Higher percentages of benzaldehyde concentration observed (up to 1%) is expected to result into negligible health risk. Although the occurrence of possible life-threatening situation, or exacerbation of preexisting patient conditions that could lead to life-threatening situations, could not be ruled out. To date, Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lots listed in the table above.


To implement this recall, please take the following actions: 

1.      Immediately examine your inventory and quarantine product subject to the recall. 

2.      Immediately discontinue distribution of the above listed lots. Meitheal will issue a credit memo or check covering the quantity of your returned product. 

3.      Return product to:

Integrated Commercialization Solutions, Inc. (ICS)

6450 LaSalle Drive

Lockbourne, OH 43137

 NOTE: Return shipment is free of charge. A Return Goods Authorization (RGA), a pre-printed, pre-paid return label will be provided to you for product return. Please submit the recall response form with the necessary information to [email protected] and a RGA and call tags will be issued. If you have further questions regarding the recall please contact Customer Service at 844-824-8426. 

4.      If you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers should include a copy of this recall notification letter and response form.


This recall should be carried out to the user level.  

Your assistance is greatly appreciated. We apologize for any inconvenience this may cause you. 

If you have any questions, please do not hesitate to call our Customer Service at 844-824-8426, weekdays 8:00AM to 6:00PM CST, to address any concerns that you may have.  


Gail Giambi

Vice President of Quality

Meitheal Pharmaceuticals, Inc.

8700 W. Bryn Mawr, Suite 600S

Chicago, IL 60613

[email protected]

(o) 224-443-4526

(c) 847-271-3778

 Download the recall response form: Glycopyrrolate Recall Form

This Website Uses Cookies

This website uses cookies to help give you the best experience when you visit. By clicking “Accept Cookies,” you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and help us make improvements to our site. You can read more about our use of cookies in our Privacy Policy.

Manage Consent Preferences

Always Active

Necessary cookies enable core functionality such as security and accessibility. You may disable these by changing your browser settings, but this may affect how the website functions.

These cookies are set to provide quantitative measures of website visitors. Information collected with these cookies is used in operations to measure website performance. With the usage of these cookies we are able to count visits and traffic sources to improve our site. The data is collected in a way that does not directly identify anyone.
Accept all cookies Confirm my choices