FDA Drug recall D-0592-2018
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 Ameri…
- FDA Drug
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of 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 Ameri… by American Pharmaceutical Ingredients, citing stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0592-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-07 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Pharmaceutical Ingredients |
| Distribution | US |
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
Reason
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Identifiers
| code_info | Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0592-2018%22
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