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Lilly Glucagon Emergency Kit - recalled due to loss of potency, USA

2 years ago •source www.fda.gov

Recall notice

Lilly Glucagon Emergency Kit - recalled due to loss of potency photo #1

United States

Company name: Eli Lilly and Company
Brand name: Lilly
Product recalled: Glucagon Emergency Kit
Reason of the recall: Loss of potency
FDA Recall date: September 26, 2021
Recall details: Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form.

The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.

Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. The product is packaged in a kit containing 1mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. The affected Glucagon Emergency Kit lot is D239382D and the expiration date is April 2022 (label expiry date: 04 2022). The lot number can be found on the label of the kit as well as the vial (refer to the photos provided below – Appendix A). The lot was distributed nationwide to wholesalers and retailers.

Wholesalers and Distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately.

Instructions for Wholesalers and Pharmacists: If you have distributed the recalled product, please notify any accounts or additional locations which may have received product from the recalled lot from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

Instructions for Consumers: Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center at 1-800-545-5979 for return and replacement instructions for the product (hours of operation are Monday- Friday, 9AM – 7PM EST) and should contact their health care provider for guidance. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. APPENDIX A The Lot Number is found on the kit and vial labels as can be seen in the example label below. 

Check the full recall details on www.fda.gov

Source: FDA

#drugs #recall #blood #us #sub #sugar

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I ordered 10 personalized water bottles from the Gamanor seller. Over $225. They show as delivered in tracking. I did not receive not 1 water bottle. But I did receive a personalized water bottle for an "Evelin Avila" from this Jerry Yasfbara in California.

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Medline and Centurion Convenience kits - recalled due to lack of sterility, USA

2 weeks ago •source www.fda.gov

Recall notice

In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded convenience kits containing Nurse Assist 0.9% Sodium … See More
Chloride Irrigation USP and Sterile Water for Irrigation USP. The Nurse Assist recall was issued due to the potential for a lack of sterility, which could result in non-sterile products. Medline Industries, LP has received one adverse event associated with product manufactured by Nurse Assist.

Water-based medical products that are non-sterile and potentially contaminated could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory infections. Patients who are elderly, critically ill, have weak immune systems (including newborn infants, pregnant women, and cancer patients), or have chronic diseases are particularly at risk of infection. However, other patients could also develop infections after exposure to contaminated water-based medical products.

The recall affects Medline and Centurion convenience kits that may be used at home by patients, caregivers, and home health providers, as well as convenience kits that may be used in medical settings for surgery or other medical procedures. Recalled kits include, but are not limited to, wound care kits, tracheostomy kits and catheter kits. A detailed list of recalled Medline and Centurion convenience kits, as well as an example of product labeling, can be found in the link below.

Consumers who have recalled product should stop using the product and contact Medline immediately.

Medline Industries, LP notified its direct distributors and consumers of the Nurse Assist recall by First Class Mail and email on 11/16/23, upon receipt of initial recall notification from Nurse Assist. Customers who received the recalled product were given instructions to quarantine all affected products immediately and provide Medline with a response regarding the affected quantity on hand. Upon confirmation of the affected quantity, Medline provided customers with over-labels to place on the affected inventory, with instructions for staff to remove the affected component before using the kit. The recall notification also instructed distributors and those who resold or transferred affected product to another company or individuals to notify their customers of this recall notification.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Medline Industries, LP
Brand name: Medline and Centurion
Product recalled: Convenience kits
Reason of the recall: The potential for a lack of sterility
FDA Recall date: April 08, 2024

Source: www.fda.gov
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