Why it was recalled
Lack of Assurance of Sterility
Product description
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
Lot numbers, UPCs & expiration codes
Lot #: AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23
Where it was sold
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-0944-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 13, 2023
- FDA report date
- Aug 2, 2023
- Quantity
- 102 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Original FDA data
Every field from FDA enforcement report D-0944-2023, exactly as published.
Show all FDA fields
- City
- Louisville
- State
- KY
- Status
- Ongoing
- Country
- United States
- Event ID
- 92699
- Address
- 4139 Cadillac Ct Ste 201
- Code information
- Lot #: AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23
- Postal code
- 40213-1578
- Report date
- Aug 2, 2023
- Product type
- Drugs
- Recall number
- D-0944-2023
- Classification
- Class II
- Recalling firm
- New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
- Product quantity
- 102 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 13, 2023
- Initial firm notification
- Center classification date
- Jul 24, 2023