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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 Manufacturer: 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
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0379-2026

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 Manufacturer: 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 Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027 Distribution: Nationwide within the United States Affected quantity: N/A

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