FDA-Drug2026-03-11Class II

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.

Harbin Jixianglong Biotech Co., Ltd.

Hazard

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

Sold states

Nationwide within the United States

Affected count

N/A

Manufactured in

North Of Baoan Road, East Of Changqing Street, Hulan District, Haerbin, N/A, China

Products

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0380-2026

Original summary

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. CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027. Distribution: Nationwide within the United States Affected quantity: N/A

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