FDA Drug recall D-0797-2022
Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00
- FDA Drug
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00 by Olympia Compounding Pharmacy, citing CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0797-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-04 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Olympia Compounding Pharmacy |
| Distribution | US |
Product
Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Identifiers
| code_info | Lots: a) D41019 BUD: 4/19/2022; b) D41112 BUD: 4/12/2022, D47028 BUD: 4/28/2022, F24009 BUD 3/4/2022, F41001 BUD: 6/1/2…Lots: a) D41019 BUD: 4/19/2022; b) D41112 BUD: 4/12/2022, D47028 BUD: 4/28/2022, F24009 BUD 3/4/2022, F41001 BUD: 6/1/2022, G48006 BUD: 7/14/2022, G48008 BUD: 7/8/2022, G48012 BUD: 7/12/2022, G48014 BUD: 7/14/2022, G48019 BUD: 7/9/2022, I24009 BUD: 9/9/2022, I41107 BUD: 9/7/2022 |
|---|
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-0797-2022%22
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