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Temporary importation of 0.9% Sodium Chloride Injection from Sichuan Kelun Pharmaceutical Co., Ltd. (Kelun) to assist in mitigating drug shortages in the U.S.
To prevent a shortage of large volume parenteral fluid drug products, Kelun is coordinating with the U.S. Food and Drug Administration (FDA), to temporarily import 0.9% Sodium Chloride Injection (250 mL) from Kelun’s manufacturing facility in Chengdu, China.
The Dear Healthcare Provider (DHCP) letter has been provided below and contains important product information.
Product Name |
Packaging |
Volume |
Mfg. site |
Unapproved Drug for Use in Drug Shortage NDC |
DHCP Letter |
0.9% Sodium Chloride Injection |
UniFlex |
250mL |
Chengdu, China |
84898-911-02 |
Please see the attached file |
Please contact ApiJect Systems Corp., the U.S. importer of Kelun's product (Tel: 855-826-4885) for more information.