Compounded Tirzepatide Injectable Vials Recalled for Sterility Assurance Issues
ProRx LLC is recalling 37 vials of compounded Tirzepatide injectable due to lack of sterility assurance. The 2 mL vials (10 mg/mL and 20 mg/mL) were 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 3/5 (High).
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 a Class II drug recall for compounded injectable medication with sterility assurance failures. While no illnesses or injuries have been reported, non-sterile injectables pose a serious infection risk, meeting the criteria for High severity as a risk-of-harm product.
Plain-English summary
ProRx LLC has recalled compounded Tirzepatide 2 mL injection vials at concentrations of 10 mg/mL and 20 mg/mL due to lack of assurance of sterility. The recall affects 37 vials (Lot #ProRx040924-1, BUD 10/08/2024) that were distributed nationwide in the USA.
Non-sterile injectable products carry a risk of serious infection in patients. Because the manufacturer cannot assure the sterility of these vials, patients who have received injections from the affected lot should be aware of this potential risk.
If you have received an injection from this product, contact your healthcare provider or pharmacist immediately. Do not use any remaining vials from Lot #ProRx040924-1. Healthcare providers who dispensed this product should contact patients who received injections and provide guidance on potential monitoring or follow-up care.
The recalled product
- Product
- Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable / Compounded
- Hazard
- Affected units
- 37
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 # ProRx040924-1
- BUD 10/08/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by ProRx LLC 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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