TRULICITY Dulaglutide Injection Recalled for Temperature Abuse During Distribution
Cardinal Health Inc. recalls one lot of TRULICITY (dulaglutide) injection due to temperature abuse. The product was exposed to temperatures outside the manufacturer's labeled storage conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for temperature-compromised medication. While no illnesses or injuries have been reported, temperature abuse of an injectable prescription drug represents a risk of harm, as the medication may be degraded or ineffective.
Plain-English summary
Cardinal Health Inc. is recalling one lot of TRULICITY (dulaglutide) injection, 0.75 mg/0.5mL, in 4 single-dose pens. The product was exposed to temperatures outside the manufacturer's labeled storage conditions.
The affected lot number is D484557A with an expiration date of 10/25/2023. Distribution was limited to New Mexico. TRULICITY is a once-weekly injectable prescription medication.
The FDA classified this as a Class II recall and assigned recall number D-0884-2022. Patients who received this lot should contact their healthcare provider or pharmacy regarding the recalled product.
The recalled product
- Product
- TRULICITY (DULAGLUTIDE)
- Brand
- TRULICITY
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: D484557A
- Exp: 10/25/2023.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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