The primary objective of any drug is to function as an aid in the recovery of a patient. While for any of them to reach the end user, there must be a strict sanitary control by the Federal Commission for the Protection against Sanitary Risks (Cofepris). But even with the help of the filters it is possible that some options have defects and are not detected in time. This is precisely what happens now with a drug that is presumed to suffer a loss of potency that would affect its performance. Although honestly, the pharmaceutical company in charge of its manufacture announced a massive withdrawal from the market in our country.
What happened?
In this case we refer to Eli Lilly y Compañía de Mexico SA de CV Through a statement they announced that Lot D239382C of the product R-Glucagon Lilly, Injectable Solution, could present failures. It all started with the receipt of a product complaint regarding an unusual-looking vial of glucagon, which was in liquid form rather than lyophilized powder. Research indicates that the liquid content in this vial of R-Glucagon Lilly could be related to the manufacturing process.
The use of the product, which is in liquid form prior to its reconstitution, could result in a failure in the treatment of the hypoglycemia severe due to loss of power.
Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from mild and transient discomfort to neurological damage, seizures, and even death if not treated immediately. Associated with the product complaint, Lilly was informed that the patient involved experienced a lack of effect from the drug and also reported subsequent seizures.
Glucagon is used as an anti-hypoglycemic agent and inhibitor of gastrointestinal motility indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus.
The product is packaged in a vial containing 1 mg of lyophilized powder in a 3 ml vial and is accompanied by a pre-filled syringe with 1 mL of diluent, both contained in a box with attached instructions. The affected batch of R-Glucagon Lilly is D239382C and the expiration date is May 10, 2022. The batch number can be found on the package label as well as on the vial label.
The pharmaceutical company said it is committed to manufacturing high-quality drugs for patients who need them. He also noted that the safety and quality of his products is his top priority.
Upon this notification of potential loss of drug potency, Lilly will begin the return and replacement of all recalled units. Distributors with an existing inventory of R-Glucagon Lilly Lot D239382C should stop their distribution and immediately quarantine it.
Instructions for distributors or pharmacies
If you have distributed the product: R-Glucagon Lilly, Lot D239382C, please notify additional pharmacies or customers who may have received the recalled product lot. Request that they suspend the distribution of the product immediately, proceed to the product recall and contact the Lilly Line 800 021 4636 or 5517194600 to start the return process.
Patient Instructions
Patients who currently have in their possession the product: R-Glucagon Lilly, Lot D239382C should stop using it immediately and contact the Lilly Line 800 021 4636 or 5517194600 to return the product and receive additional information. Hours of operation are Monday through Friday from 8:00 a.m. to 6:00 p.m. or via email [email protected]
Consumers or patients should contact their physician if they have experienced any problems that may be related to the use of this product.