Why it was recalled
Lack of Assurance of Sterility
Product description
Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1
Lot numbers, UPCs & expiration codes
Lot #: 03252019+51850, Exp 7/6/2020; 04252019+52098, Exp 6/29/2020; 04292019+52108, Exp 6/29/2020; 05012019+52132, Exp 10/22/2020; 05202019+52268, Exp 11/10/2020; 05222019+52290, Exp 11/10/2020; 05302019+52334, Exp 11/20/2020; 07082019+52594, Exp 12/29/2020; 07102019+52619, Exp 12/29/2020; 07292019+52762, Exp 8/12/2020; 07312019+52778, Exp 8/12/2020; 09102019+52898, Exp 1/16/2021; 09112019+52905, Exp 1/18/2021
Where it was sold
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
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-0983-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2020
- FDA report date
- Mar 11, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Original FDA data
Every field from FDA enforcement report D-0983-2020, exactly as published.
Show all FDA fields
- City
- Los Angeles
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84978
- Address
- 1990 Westwood Blvd Ste 135
- Code information
- Lot #: 03252019+51850, Exp 7/6/2020; 04252019+52098, Exp 6/29/2020; 04292019+52108, Exp 6/29/2020; 05012019+52132, Exp 10/22/2020; 05202019+52268, Exp 11/10/2020; 05222019+52290, Exp 11/10/2020; 05302019+52334, Exp 11/20/2020; 07082019+52594, Exp 12/29/2020; 07102019+52619, Exp 12/29/2020; 07292019+52762, Exp 8/12/2020; 07312019+52778, Exp 8/12/2020; 09102019+52898, Exp 1/16/2021; 09112019+52905, Exp 1/18/2021
- Postal code
- 90025-4650
- Report date
- Mar 11, 2020
- Product type
- Drugs
- Recall number
- D-0983-2020
- Classification
- Class II
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Termination date
- Dec 7, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1
- Distribution pattern
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
- Recall initiation date
- Jan 15, 2020
- Initial firm notification
- Press Release
- Center classification date
- Mar 5, 2020