Drug product
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
D-0592-2018
Product summary
- Event
- Event 79420
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1460 GM
- Official record key
drug-enforcement:D-0592-2018
Official wording
Reason: Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Code information: Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Stability Data Does Not Support Expiry