Customer Notification Recall Communication Letter
Urgent: Glycopyrrolate Injection, USP 4mg per 20mL RECALL
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 MeithealPharmaReturns@icsconnect.com 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.
Vice President of Quality
Meitheal Pharmaceuticals, Inc.
8700 W. Bryn Mawr, Suite 600S
Chicago, IL 60613
Download the recall response form: Glycopyrrolate Recall Form