Drug product
IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800
D-0748-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-0748-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 07162019@20 Exp. 01/12/2020; 12102019@17 Exp. 06/07/2020; 07162019@20 Exp. 01/12/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility