Drug product
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
D-0343-2019
Product summary
- Event
- Event 81629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 vials
- Official record key
drug-enforcement:D-0343-2019
Official wording
Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Code information: Lot: 10292018:21 Exp. 3/31/2019
Distribution pattern: WA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility