Drug product
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
D-1518-2022
Product summary
- Event
- Event 90798
- Status
- Completed
- Classification
- Class II
- Quantity
- 8 syringes
- Official record key
drug-enforcement:D-1518-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 08012022@14 BUD: 08/31/2022; 08192022@7 BUD: 09/23/2022
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility