Why it was recalled
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Product description
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Lot numbers, UPCs & expiration codes
Lot #: 748127, Exp 9/24/2024
Where it was sold
USA Nationwide
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-0511-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Apr 20, 2024
- FDA report date
- Jun 5, 2024
- Quantity
- 751 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-0511-2024, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 94550
- Address
- 3831 Golf Dr Ste A
- Code information
- Lot #: 748127, Exp 9/24/2024
- Postal code
- 77018-5218
- Report date
- Jun 5, 2024
- Product type
- Drugs
- Recall number
- D-0511-2024
- Classification
- Class I
- Recalling firm
- Revive Rx LLC dba Revive Rx Pharmacy
- Product quantity
- 751 vials
- Reason for recall
- Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Apr 20, 2024
- Initial firm notification
- Telephone
- Center classification date
- May 29, 2024