Drug product
CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800
D-0720-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 vials
- Official record key
drug-enforcement:D-0720-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 08212019@29 Exp. 02/17/2020; 07152019@12 Exp. 01/11/2020; 07082019@26 Exp. 01/04/2020;
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility