Temporary Importation of SERB’s Calcium Edetate de Sodium Injection to Address Drug Shortage
Dear Healthcare Professional:
Due to current critical shortage of Calcium Disodium Versenate Injection in the United States (US) market, BTG International Inc. (BTG), in conjunction with SERB SAS (SERB), is coordinating with the US Food and Drug Administration (FDA) to temporarily import non-FDA approved Calcium Edetate de Sodium Injection (500 mg/ampule, 5 g/carton) that is authorized for marketing in France. The FDA has not approved SERB’s Calcium Edetate de Sodium Injection in the US. Calcium Edetate de Sodium is indicated for the treatment of lead poisoning.
At this time, BTG and/or its distributor, ASD Healthcare, are the only U.S. distributors of the imported Calcium Edetate de Sodium Injection.
Effective immediately, BTG will import and distribute the following presentation of SERB’s Calcium Edetate de Sodium injection to address the critical shortage:
Click here for Summary of Product Characteristics (PDF)
The ampule and carton labels will display the text intended for marketing in France with both English and French translations. It is important to note that there are differences in the format and content of the labelling between Calcium Disodium Versenate Injection and SERB’s Calcium Edetate de Sodium Injection. The imported product has a concentration of 500 mg/10ml 50 mg/ml, while the FDA approved U.S. version has a concentration of 200 mg/mL. Both products are contraindicated for patients with kidney disease. The imported product is contraindicated for patients with an allergy against calcium edetate and also in combination with digitalis. The FDA approved U.S. version is contraindicated against patients with hepatitis or have had periods of anuria. See the table on page 2 for identification of the differences.
The barcode on the imported product label will not register accurately on US scanning systems. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients. In addition, the packaging of the imported product does not include serialization information. SERB’s Calcium Edetate de Sodium Injection does not meet US Drug Supply Chain Security Act (DSCSA) requirements
SERB’s Calcium Edetate de Sodium Injection is available only by prescription in the US. However, the imported lot does not have the statement “Rx only” on their labelling. Please refer to the package insert for full prescribing information.
To order: Please contact:
Phone: 800.746.6273 / Fax: 800.547.9413 / Email: firstname.lastname@example.org
Please ensure that your staff and others in your institution who may be involved in the administration of Calcium Edetate de Sodium Injection receive a copy of this letter, review the information and maintain a copy of this letter with the product at all times.
Adverse Event Reporting: Healthcare providers should report adverse events associated with the use of SERB’s Calcium Edetate de Sodium Injection to BTG at 844-293-0007. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:
or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form or submit by fax to 1-800-FDA-0178 (1-800-332-0178).
Questions/Support: If you have any questions about the information contained in this letter, any quality related problems, or questions on the use of SERB’s . We remain at your disposal to answer any questions you may have about our product; and provide more information if needed.
Chief Innovation Officer