Why it was recalled
Lack of sterility assurance.
Product description
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
Lot numbers, UPCs & expiration codes
Lot, expiry: AL-07232019@99, exp 9-23-2019; AL-07312019@99, exp 9-30-2019; AL-08132019@99, exp 10-13-2019; AL-08272019@901, exp 10-27-2019; AL-08282019@909, exp 10-28-2019; Al-09032019@903, exp 11-3-2019
Where it was sold
Distributed Nationwide in the USA
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-0523-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 1, 2019
- FDA report date
- Dec 4, 2019
- Quantity
- 2981.62 mL
- 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-0523-2020, exactly as published.
Show all FDA fields
- City
- Louisville
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 84189
- Address
- 4139 Cadillac Ct Ste 201
- Code information
- Lot, expiry: AL-07232019@99, exp 9-23-2019; AL-07312019@99, exp 9-30-2019; AL-08132019@99, exp 10-13-2019; AL-08272019@901, exp 10-27-2019; AL-08282019@909, exp 10-28-2019; Al-09032019@903, exp 11-3-2019
- Postal code
- 40213-1578
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0523-2020
- Classification
- Class II
- Recalling firm
- New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
- Product quantity
- 2981.62 mL
- Termination date
- Mar 9, 2023
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Oct 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 25, 2019