D-1040-2017 Class II Terminated
FDA drug recall D-1040-2017 was initiated by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical on July 12, 2017 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated January 14, 2019). Affected quantity: 120 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2017
- Initiation Date
- July 12, 2017
- Termination Date
- January 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 vials
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
Reason for Recall
CGMP Deviations
Distribution Pattern
There were only one customer in California
Code Information
Lot # 03022017+44906; BUD 08/29/17