Tirzepatide Injections recalled due to lack of sterility assurance
Thrive Health Solutions is recalling Tirzepatide Injections 30mg/mL pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II drug recall involving a sterility assurance issue with injectable medication. Lack of sterility in injectable products poses a serious risk of infection and can lead to hospitalization, meeting the Severe criteria.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) is recalling Tirzepatide Injections, 30mg/mL, pre-filled syringes, Lot H388348. The recall affects 4 syringes per package and applies to distribution throughout the USA.
The product is being recalled due to lack of assurance of sterility. Tirzepatide is an injectable diabetes and weight-loss medication, and failure to ensure sterility can result in serious infections from contamination.
Patients who have received this product should contact their healthcare provider to discuss whether they may have been affected and whether additional medical evaluation is needed.
The recalled product
- Product
- Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Affected units
- 4
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 (1)
- Lot: H388348
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) 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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