Tirzepatide Injectable Vials Recalled for Sterility Assurance
ProRx LLC is recalling Tirzepatide 20 mg/2mL injectable vials nationwide due to lack of assurance of sterility. Patients who received vials from lot ProRx051424 should contact their healthcare provider.
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 an FDA Class II recall for a risk-of-harm injectable product where no injury has been reported. Lack of sterility assurance in an injectable medication poses potential infection risk, but no illnesses or injuries are documented.
Plain-English summary
ProRx LLC is recalling Tirzepatide 20 mg/2mL injectable vials distributed nationwide. The affected product is a 2mL multiple-dose vial with lot number ProRx051424, bearing a beyond-use date of 11/13/2024. Approximately 1,489 vials are affected by this recall.
The recall was initiated due to lack of assurance of sterility. Tirzepatide is an injectable medication used in diabetes and weight management treatment. Loss of sterility assurance in an injectable product poses a potential infection risk if the product is used.
Patients who have received or may receive vials from this lot should contact their healthcare provider or pharmacist immediately. Do not use the product if you have a vial from the affected lot.
The recalled product
- Product
- TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
- Manufacturer
- ProRx LLC
- Category
- Drug — Injectable
- Affected units
- 1,489
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 # ProRx051424
- BUD 11/13/2024
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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