Why it was recalled
Lack of sterility assurance.
Product description
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
Lot numbers, UPCs & expiration codes
Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020
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-0772-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 166 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Assurance Infusion
Original FDA data
Every field from FDA enforcement report D-0772-2020, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84546
- Address
- 2626 S Loop W Ste 555
- Code information
- Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020
- Postal code
- 77054-2652
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0772-2020
- Classification
- Class II
- Recalling firm
- Assurance Infusion
- Product quantity
- 166 vials
- Termination date
- Oct 27, 2021
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2020