Thousands of Trulicity Autoinjector Devices Labeled as 0.75 mg Might Contain 1.5 mg (i.e., a "double-dose")
(Posted by Tom Lamb at Drug Injury Watch)
A Trulicity recall back in August - September 2021 by Eli Lilly & Company was due to a dose labeling error involving a single lot of Trulicity (dulaglutide). That does not sound too alarming at first glance, but this incident becomes more concerning as a Trulicity drug safety issue when one takes a closer look.
First, 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".
Second, this 2021 Trulicity 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.
Third, when the FDA issued its Enforcement Report for that Trulicity recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.
Fourth, it was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.
Fifth, 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.
Sixth, 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.
Lastly, even though the FDA designated this 2021 Trulicity 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.
For more details, see these two source documents:
1. Recall Enforcement Report for FDA recall D-0773-2021, which starts as follows:
Drug Recall Enforcement Report Class II voluntary initiated by Eli Lilly & Company, originally initiated on 08-19-2021 for the product Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 The product was recalled due to labeling: label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 ml actually contain 1.5 mg / 0.5 ml of product. The product was distributed nationwide and the recall is currently ongoing.
2. California State Board of Pharmacy Trulicity recall alert, which provides an important update:
The Board of Pharmacy has received notice of the following product recall. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required.
NOTE: UPDATED EXPIRATION DATE
Description: TRULICITY 0.75MG/0.5ML PEN 4
Lot #: D396436C
Exp Date: 01/27/2023
Eli Lilly is recalling the above item/lot due to a dose labeling error. This recall is to the retail level. Affected product started shipping June 14, 2021.
Significantly, neither of those two source documents tells us how many of the double-dose Trulicity boxes were dispensed by pharmacies to patients rather than returned by pharmacies to Eli Lilly.
In addition, even though the expiration date for this recalled double-dose Trulicity is stated as "01/27/2023", patients often overlook this type of preventive information.
For example, we were contacted by a woman who reportedly used one of these recalled Trulicity products in mid-February 2023 and was subsequently hospitalized for three days for seizures that may have been related to using twice the amount of Trulicity that had been prescribed by her doctor.
Given that this 2021 Eli Lilly / FDA Trulicity recall was rather "low-profile", and 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.
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.
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