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| Exchange Disseminated Time | Sanofi India Ltd has informed BSE that :
"The Business Standard has published an article today on recall of some batches of the Company's product Combiflam®.
The newspaper sought our comments on the issue which were provided to them. Our clarifications have been published in the said article.
In response to further queries received from the media, the following additional clarifications are being provided by the Company:
Four batches of Combiflam® have been ordered to be recalled due to delay in disintegration time of the tablet. This qualifies as a Class III recall wherein consumption of the product is not likely to cause adverse health consequences.
We have acted immediately, and completed the recall for two batches, while the recall of the remaining two batches is ongoing.
The Company has analysed the issue and appropriate remedial steps have been taken to ensure that the tablets disintegrate within the specified timelines. Doctors and patients can be assured that there is no impact on the safety and efficacy of the product.
Consequently, we do not expect the recall to affect the Combiflam® sales." |
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