Why it was recalled
CGMP Deviations
Product description
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
Lot numbers, UPCs & expiration codes
Lot # 03022017+44906; BUD 08/29/17
Where it was sold
There were only one customer in California
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-1040-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 12, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 120 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Original FDA data
Every field from FDA enforcement report D-1040-2017, exactly as published.
Show all FDA fields
- City
- Los Angeles
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 77757
- Address
- 1990 Westwood Blvd Ste 135
- Code information
- Lot # 03022017+44906; BUD 08/29/17
- Postal code
- 90025-4650
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1040-2017
- Classification
- Class II
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Product quantity
- 120 vials
- Termination date
- Jan 14, 2019
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
- Distribution pattern
- There were only one customer in California
- Recall initiation date
- Jul 12, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2017