Fosfalyugel

2022: Withdrawal of the drug due to exceeding the permissible lead norm

In March 2022, the Federal Service for Supervision of Health Care (Roszdravnadzor) on the basis of announced the decision of Opella Helskea France SAS ( included in the Sanofi group), which is the holder of registration certificate P N012655/01 from the 05.03.2009 for drugs with the trade name "Phosphalugel," to withdraw from circulation some series of drugs due to the detection in them of excess of the permissible daily lead content. We are talking about the drug "Phosphalugel, gel for ingestion 16 g, sachets (20), cardboard packs."

In Russia, the Sanofi drug for gastritis Phosphalyugel is recalled. It has too much lead

"The territorial bodies of Roszdravnadzor shall ensure control over the removal from circulation of the series of medicines listed in the appendix and compliance by the subjects of circulation of medicines with the above requirements of the legislation in the field of circulation of medicines. Inform Roszdravnadzor about the work carried out, "the department said in a statement.

List of drug series subject to seizure: 128107. 128108. 128109. 128129. 128131. 128132. 128133. 128134. 128137. 128138. 028104. 028105. 028106. 028107. 028111. 028112. 028113. 028218. 028219. 028283. 028284. 028285. 028286. 028287. 028288. 028289. 028646. 028647. 028648. 028652. 028653. 028083. 028096. 028132. 028173. 028222. 128097. 128098.

Signs of lead poisoning are increased blood pressure, joint and muscle pain, memory or concentration problems, headache, abdominal pain, mood disorders, reduced sperm count and abnormal sperm, miscarriage or premature birth in pregnant women.

Indications for the reception of Phosphalugel:

• gastric and duodenal ulcer;
• gastritis with normal or enhanced secretory function;
• hernia of the esophageal opening of the diaphragm;
• non-ulcer dyspepsia syndrome;
• functional diarrhea;
• functional diseases of the colon;
• gastric and intestinal disorders caused by intoxication, administration of drugs, irritants (acids, alkalis), alcohol.

Statement of Roszdravnadzor on the recall of Phosphalugel