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WarningRecall #D-0380-2026Drug / Pharmaceutical

Harbin Jixianglong Biotech Co. Recalls Semaglutide

Harbin Jixianglong Biotech Co., Ltd. · Class II — Moderate Risk

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).

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; 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 for Recall

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

FDA Classification

Class II — Moderate Risk

A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution

Nationwide within the United States

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

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