Why it was recalled
Lack of Assurance of Sterility
Product description
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot #AL07202021@901, Exp 9/18/21; Lot #AL07272021@901, Exp 9/25/21; Lot #AL08032021@901, Exp 10/2/21; Lot #AL08102021@901, Exp 10/9/21; Lot #AL08172021@901, Exp 10/16/21; Lot #AL08242021@901, Exp 10/23/21
Where it was sold
Nationwide within the United States
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-0899-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 22, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 1,347 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-0899-2021, exactly as published.
Show all FDA fields
- City
- Louisville
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 88733
- Address
- 4139 Cadillac Ct Ste 201
- Code information
- Lot, expiry: Lot #AL07202021@901, Exp 9/18/21; Lot #AL07272021@901, Exp 9/25/21; Lot #AL08032021@901, Exp 10/2/21; Lot #AL08102021@901, Exp 10/9/21; Lot #AL08172021@901, Exp 10/16/21; Lot #AL08242021@901, Exp 10/23/21
- Postal code
- 40213-1578
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0899-2021
- Classification
- Class II
- Recalling firm
- New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
- Product quantity
- 1,347 vials
- Termination date
- May 12, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 22, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 30, 2021