Compounded Tirzepatide Injections Recalled Nationwide Due to Sub-Potency
Revive Rx is recalling 45 vials of compounded tirzepatide 10 mg/0.5 mL injections nationwide due to sub-potency. Patients should contact their healthcare provider about their medication.
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: Sub-potency in a compounded injectable medication creates a risk of harm—patients expecting full therapeutic effect will receive insufficient active ingredient. Although the source does not report illnesses or injuries, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' matching Score 3 rubric criteria.
Plain-English summary
Revive Rx LLC is recalling 45 vials of compounded tirzepatide 10 mg/0.5 mL sterile solution due to sub-potency. The affected lot is 1643397, with a beyond-use date of 10/16/2023. The product was intended for nationwide distribution in the United States.
Sub-potency means the vials contain insufficient active tirzepatide compared to the labeled 10 mg per 0.5 mL dose. The FDA classified this as a Class II recall. The firm initiated the recall voluntarily on May 11, 2023.
If you received medication from lot 1643397, contact your healthcare provider or pharmacy immediately. Do not use the medication without consulting your healthcare provider about alternative treatments.
The recalled product
- Product
- Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
- Manufacturer
- Revive Rx LLC dba Revive Rx Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sub-potency
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: 1643397 BUD: 10/16/2023
Distribution
Distributed nationwide across the United States.
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