French pharmaceutical giant Sanofi is voluntarily recalling its popular anti-allergic brand Allegra suspension syrup and painkiller drug Combiflam suspension from the Indian market, News18 learnt.
Both the drugs, which are prescribed to children, are being recalled from hospitals, distributors and retailers as a “precautionary” measure triggered by the incidents of “microbiological contamination” which is still under investigation.
Allegra suspension is typically given to children for managing symptoms stemming from allergic conditions like hay fever, watery eyes, runny nose, sneezing, itching and common cold, whereas combiflam suspension is effective in reducing fever and relieving pain and swelling in both infants and children.
According to the letter dated July 19 issued by the drug major to distributors, accessed by News18, “This voluntary precautionary recall is in continuation of previous recall of products Depura Kids and Depura Sugar-Free (Cholecalciferol) vide letters dated 26.03.2024 and 26.06.2024 respectively, due to microbiological contamination still under investigation at the manufacturing site.”
“As a matter of abundant precaution, this voluntary precautionary recall of the batches mentioned below is initiated because the products are manufactured in the same facility,” it added.
Brand Depura, which the circular mentions as being affected earlier, is a supplement of Vitamin D3 given to young children and infants to support their calcium requirement.
The letter clarifies that this recall is applicable and restricted only to the batch numbers mentioned. The annexure shows the batch details for Allegra Suspension 100ml and Combiflam Suspension 60ml manufactured in 2022, 2023 and 2024.
The company spokesperson told News18 in an emailed response that as “a precautionary measure, we are proceeding with a voluntary recall of products that were manufactured at a contracted manufacturing site.”
“The products are Allegra Suspension, Combiflam Suspension,” the spokesperson explained, while adding that “this voluntary recall concerns all batches of the products named and within shelf-life that are stocked with distributors, wholesalers, pharmacies, retail establishments and hospital levels respectively”.
The emailed response added that the recall decision is due to a matter that is still under investigation. “We are working towards resuming the supplies of the above-mentioned products at the earliest.” It said that patient safety is at the forefront of our values at Sanofi, and the company is committed to ensuring that they make available quality products in the market.
STOPPING SALE OF PRODUCTS FROM THE MANUFACTURING SITE
In addition to recalling the affected batches, Sanofi has decided to halt further sales of these products manufactured at the same site. The company’s communication advises distributors, hospitals, and retailers to immediately cease sales and use of specific batch numbers listed in the annexure provided.
“This is to inform you that Sanofi Consumer Healthcare India Limited has taken a decision to voluntarily stop further sale and initiate a precautionary recall of the batches mentioned in the annexure for Allegra Suspension and Combiflam Suspension from the market, up to the levels of distributor, hospitals, and retailers.”
“Our records show that these batches were invoiced and shipped out, from our CFA (clearing and forwarding agents) to the distributors. Therefore, till further notice, effective sales stoppage of these batches will be undertaken with distributors, hospitals and retailers who were invoiced and delivered these batches, in case they are still holding the same at their premises and shelves respectively.”
The company has advised the retailers, hospitals and distributors at all levels “to stop further sales of the stocks only bearing the batch numbers in case it is in stock with you”.
“Check your batch-wise stocks and isolate the stocks of the above-mentioned batch numbers,” it said.
It also asks distributors to inform the retailers and hospitals that “they should stop further sale and use of these batches in case they are holding stocks and ask for a full recall of quantities lying with them”.
