Sanofi initiates voluntary recall of Allegra, Combiflam suspensions in India over contamination in some batches
French Multinational Pharmaceutical Company Sanofi is voluntarily initiating a precautionary recall of Allegra Suspension syrup (Fexofenadine Hydrochloride Suspension) and Combiflam Suspension (Ibuprofen and Paracetamol Suspension) from distributors, hospitals and retailers in the Indian market as a precautionary measure triggered "due to microbiological contamination," which is "still under investigation."
The pharma company has issued a circular to all pharma distributors, hospitals and retailers in the Indian market regarding a "temporary halt" of sales of its Allegra Suspension syrup (Fexofenadine Hydrochloride Suspension) and Combiflam Suspension (Ibuprofen and Paracetamol Suspension).
The circular assessed by ANI stated, "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 annexure for Allegra Suspension and Combiflam Suspension from the market, up to the levels of distributor, hospitals, and retailers.
The voluntary precautionary recall is for particular some batches, "This voluntary precautionary recall is in continuation of the previous recall of products Depura Kids and Depura Sugar Free (Cholecalciferol) via letters dated 26.03.2024 and June 26, 2024, respectively, due to microbiological contamination still under investigation at the manufacturing site," it added.
"As a matter of abundant precaution, this voluntary precautionary recall of the batches mentioned below is initiated because the Product are manufactured in the same facility," the circular stated.
Allegra Suspension is usually given to children to treat a wide range of symptoms caused due to allergic conditions such as hay fever, urticaria (hives), conjunctivitis (red, itchy eye), and common cold. These symptoms include watery eyes, runny nose, sneezing, and itching among others.
Combiflam Suspension helps lower body temperature (fever) and reduce pain and inflammation (redness and swelling) both in infants and children.
The recall is applicable and restricted for some batches. For Allegra Suspension 100ml: Manufactured Year 2022:- Batch No : AL1222001 to AL1222029, Manufactured Year 2023:- Batch No : AL1223001 to AL1223071 Manufactured Year 2024:- Batch No : AL1224001 to AL1224026. Batch Details for Combiflam Suspension 60ml: Manufactured Year 2022- Batch no. CM1222004 to CM1222051 Manufactured Year 2023- Batch no. CM1223001 to CM1223185 Manufactured Year 2024- Batch no. CM1224001 to CM1224073.
"Our records show that these batches were invoiced and shipped out, from our CFA 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 circular said further.
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