There was a relatively “low profile” Trulicity double-dose recall by Eli Lilly & Company back in 2021. Because there may still be thousands of double-dose Trulicity injectors in patients’ homes, we are concerned that this is an ongoing Trulicity drug safety issue. Here are seven reasons why:
- Some Trulicity autoinjector devices labeled as 0.75 mg/0.5 mL, in fact, contain 1.5 mg/0.5 mL of product. As such, those Trulicity products can be viewed as “defective”.
- This 2021 Trulicity double-dose recall affects 119,539 boxes of Trulicity 0.75 mg/0.5 mL single-dose pens, four pens per box (NDC 0002-1433-80), from lot D396436C.
- When the FDA issued its Enforcement Report for that Trulicity double-dose recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.
- It was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.
- While the mislabeled Trulicity autoinjector devices were distributed throughout the United States, it appears that the associated Trulicity recall was only down to the retail level.
- It apparently took Eli Lilly at least two months, from mid-June 2021 to mid-August 2021 — to realize that this double-dose lot of Trulicity had been shipped to US pharmacies to dispense for use by patients.
- Even though the FDA designated this 2021 Trulicity double-dose recall as “Class II” — by definition, meaning that use of this product could cause temporary or medically reversible adverse health consequences — that FDA Class II designation also indicates there is a remote possibility of serious harm.
If you or someone you know may have suffered an adverse reaction as a result of using a Trulicity autoinjector device which was labeled as 0.75 mg but, later, it was determined the product contained 1.5 mg of Trulicity (a “double-dose”), we would be interested in hearing more about that event. It is possible that a Trulicity drug injury case could be filed against Eli Lilly, depending on the circumstances. For that purpose, one can submit a Case Evaluation Form to us for review.[Read article in full at original source]
Strictly Confidential, No Obligation