D-0522-2017 Class II Terminated
FDA drug recall D-0522-2017 was initiated by Synergy Rx on February 10, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: There are also CGMP Deviations. The recall status is terminated (terminated May 23, 2017). Affected quantity: 1809 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 22, 2017
- Initiation Date
- February 10, 2017
- Termination Date
- May 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1809 vials
Product Description
Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Reason for Recall
Lack of Assurance of Sterility: There are also CGMP Deviations.
Distribution Pattern
Nationwide within the United States
Code Information
All Lots