FDA Recall D-0771-2023
Revive Rx LLC dba Revive Rx Pharmacy · Houston, TX
Class II Ongoing 1099 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
Sub-potent Drug
Recall record
- Recall number
D-0771-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2023-05-11
- Classified by FDA Center
- 2023-05-25
- FDA published
- 2023-05-31
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
- Firm location
- Houston, TX
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.