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Harbin Jixianglong Biotech Co., Ltd.: 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, N

DrugsSource: FDA (drug) · Date: 2026-03-11

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Harbin Jixianglong Biotech Co., Ltd.
Product
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.
Reason / hazard
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-02-13
Code info
Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Haerbin
State
N/A
Country
China
Event id
98438
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