FDA DrugsClass II
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b...
Published: March 11, 2026Recall ID: D-0379-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Product Description & Identification
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
Additional Source Details
| Field | Value |
|---|---|
| City | Haerbin |
| State | N/A |
| Event id | 98438 |
| Address 1 | North Of Baoan Road, East Of Changqing Street |
| Address 2 | Hulan District |
| Code info | Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027 |
| Postal code | N/A |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260213 |
| Initial firm notification | |
| Center classification date | 20260302 |
Overview
- Recalling FirmHarbin Jixianglong Biotech Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States