Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Trulicity (dulaglutide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
0002-1433-80
Compare with the code on your package — it is the most precise check available.
Drug: Dulaglutide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Trulicity Dulaglutide NDC 00002-1433 |
.75 mg/.5mL | Injection, Solution Subcutaneous |
Eli Lilly and Company | Rx |
- Recalling firm
- Eli Lilly & Company
- NDC code
- 0002-1433-80
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0773-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dulaglutide recalls
See all
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Other recalls by Eli Lilly & Company
All 2021 recalls
Class II · Moderate risk
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CGMP Deviations
Class I · High risk
Glucagon Emergency Kit for Low Blood Sugar
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class III · Low risk
ERBITUX CETUXIMAB Injection
Labeling: Missing label; potential for missing primary container label on the vial.
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