D-0379-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- February 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027