Phosphalugel

2022: Recall of the drug due to exceeding the permissible lead limit

In March 2022, the Federal Service for Supervision in the Field health care () Roszdravnadzor based on the information of LLC "" Opella Helskea announced the decision of Opella Helskea France SAS (included in the group), Sanofi which is the holder of the marketing authorization P N012655/01 from the 05.03.2009 for drugs with the trade name "Phosphalugel," withdraw from circulation some batches of the drug due to the detection in them of exceeding the permissible daily limit of lead content. We are talking about the drug "Phosphalugel, oral gel 16 g, sachet (20), cardboard packs."

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

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

List of drug product batches subject to withdrawal: 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 high blood pressure, joint and muscle aches, memory or concentration problems, headache, abdominal pain, mood disorders, decreased sperm count, and abnormal semen, miscarriage, or premature birth in pregnant women.

Indications for the reception of "Phosphalugel":

• peptic ulcer of the stomach and duodenum;
• gastritis with normal or increased secretory function;
• hernia of the esophageal orifice of the diaphragm;
• non-ulcerative dyspepsia syndrome;
• functional diarrhea;
• functional diseases of the colon;
• gastric and intestinal disorders caused by intoxication, administration of drugs, irritants (acids, alkali), alcohol.

Roszdravnadzor statement on the recall of Phosphalugel