Sanofi’s children allergy medications recalled in India due to possible microbiological contamination
James Josh Fact checked by:TMN Team Aug 12, 2024 1 month, 5 days, 9 hours, 51 minutes ago
Pharma News: In a significant development affecting the Indian pharmaceutical market, French multinational pharma giant Sanofi has announced the voluntary recall of two popular children's medications - Allegra Suspension (Fexofenadine Hydrochloride Suspension) and Combiflam Suspension (Ibuprofen and Paracetamol Suspension). The recall has been initiated as a precautionary measure due to concerns over potential microbiological contamination in certain batches of these products.
Sanofi’s children allergy medications recalled in India due to possible microbiological contamination
Voluntary Recall to Ensure Safety
Sanofi has issued a circular to pharmaceutical distributors, hospitals, and retailers across India, informing them of the decision to temporarily halt the sales of Allegra Suspension and Combiflam Suspension. The company is urging all stakeholders to comply with the recall to prevent any potential risks associated with the consumption of these products.
According to the circular, the recall is part of a broader precautionary strategy. It follows the earlier recall of Depura Kids and Depura Sugar Free (Cholecalciferol) products in March and June 2024, respectively, also due to microbiological contamination concerns. Sanofi emphasized that this latest recall is being carried out as "a matter of abundant precaution" since the affected products were manufactured in the same facility as the previously recalled items.
It is not known if the same products available in elsewhere in Asia are also possibly contaminated or if other products lines from Sanofi are safe. There have been no other
Pharma News coverages reassuring the safety of Sanofi products elsewhere in Asia so far.
The Medications Involved
Allegra Suspension is a widely used antihistamine prescribed to children to alleviate symptoms of various allergic conditions, including hay fever, urticaria (hives), conjunctivitis (red, itchy eyes), and the common cold. The medication helps to relieve symptoms such as watery eyes, runny nose, sneezing, and itching, making it a staple in pediatric allergy treatment.
Combiflam Suspension, on the other hand, is a combination of ibuprofen and paracetamol, used to reduce fever and relieve pain and inflammation in children and infants. This medication is commonly administered to treat conditions ranging from mild fever to more serious inflammatory conditions.
The recall specifically targets certain batches of these suspensions manufactured in 2022, 2023, and 2024. The circular provides detailed information about the batch numbers affected, urging distributors, hospitals, and retailers to halt sales and return any remaining stock.
Details of the Affected Batches
Sanofi has outlined the specific batches of Allegra and Combiflam Suspensions that are subject to the recall:
-Allegra Suspension 100ml:
Manufactured in 2022: Batch No: AL1222001 to
AL1222029
Manufactured in 2023: Batch No: AL1223001 to AL1223071
Manufactured in 2024: Batch No: AL1224001 to AL1224026
-Combiflam Suspension 60ml:
Manufactured in 2022: Batch No: CM1222004 to CM1222051
Manufactured in 2023: Batch No: CM1223001 to CM1223185
Manufactured in 2024: Batch No: CM1224001 to CM1224073
The company has instructed that effective sales stoppage of these batches be implemented immediately. Distributors, hospitals, and retailers who have already received these batches are required to cease distribution and return the products to Sanofi.
Ongoing Investigation and Safety Measures
Sanofi has made it clear that the decision to recall these products is precautionary, as the contamination is still under investigation. The recall is part of a series of measures taken by the company to ensure the safety and well-being of its consumers, especially children, who are the primary users of these medications.
The circular from Sanofi also reassures healthcare providers and consumers that the recall is limited to specific batches and that other batches and products are not affected. The company has not disclosed the nature of the microbiological contamination, stating that the investigation is ongoing.
Impact on the Market and Public Health
The recall of Allegra Suspension and Combiflam Suspension is likely to have a significant impact on the Indian pharmaceutical market, given the widespread use of these medications in pediatric care. Sanofi's prompt action to address potential safety concerns is crucial in maintaining public trust in pharmaceutical products.
However, the recall also underscores the challenges that pharmaceutical companies face in ensuring the safety and quality of their products, particularly in large and complex markets like India. The ongoing investigation into the contamination will be closely watched by healthcare providers, regulatory bodies, and consumers alike.
Conclusion
Sanofi’s recall of Allegra and Combiflam suspensions is a precautionary measure to protect public health amid concerns of microbiological contamination. The recall affects specific batches manufactured between 2022 and 2024, and is a continuation of previous recalls linked to the same manufacturing site. While this recall presents challenges for pediatric healthcare in India, it also underscores the importance of stringent quality control in pharmaceutical production. As investigations continue, Sanofi remains committed to ensuring the safety of its products and the well-being of its consumers.
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