Recalls / Class II
Class IID-1040-2017
Product
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
- Affected lot / code info
- Lot # 03022017+44906; BUD 08/29/17
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1990 Westwood Blvd Ste 135, N/A, Los Angeles, California 90025-4650
Distribution
- Quantity
- 120 vials
- Distribution pattern
- There were only one customer in California
Timeline
- Recall initiated
- 2017-07-12
- FDA classified
- 2017-07-31
- Posted by FDA
- 2017-08-09
- Terminated
- 2019-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1040-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.