Drug product
HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
D-0237-2021
Product summary
- Event
- Event 87076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2400 vials
- Official record key
drug-enforcement:D-0237-2021
Official wording
Reason: CGMP deviations: Lack of potency testing.
Code information: Lot #: 40548, Use By Date, 01/30/2021.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP deviations