Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; ...
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; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
Affected Products
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; e) 100g, NDC 84385-106-05Manufacturer: 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 | Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 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