Why it was recalled
Sub-potent Drug
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 1643397 BUD: 10/16/2023
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0771-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 11, 2023
- FDA report date
- May 31, 2023
- Quantity
- 45 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
Original FDA data
Every field from FDA enforcement report D-0771-2023, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 92329
- Address
- 3831 Golf Dr Ste A
- Code information
- Lot: 1643397 BUD: 10/16/2023
- Postal code
- 77018-5218
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0771-2023
- Classification
- Class II
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
- Product quantity
- 45 Vials
- Reason for recall
- Sub-potent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 11, 2023
- Initial firm notification
- Letter
- Center classification date
- May 25, 2023