Maharashtra FDA Cancels Cipla Licences, Seizes Reactin Plus Stock in Pune
Maharashtra FDA Cancels Cipla’s Pune Drug Sale Licences Over Reactin Plus Violations
Regulator Seizes Stock Worth Over Rs 11 Lakh and Orders Market Recall
Pune: The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla’s Pune facility after finding violations related to the packaging, storage and distribution of Reactin Plus.
The regulator also seized Reactin Plus stock valued at more than Rs 11 lakh and ordered the company to recall the product from the market.
The action followed an inspection of the facility, during which FDA officials reportedly found irregularities in the handling and distribution of the medicine. The violations raised concerns over compliance with prescribed drug safety and storage standards.
The Maharashtra FDA has directed that the affected stock be withdrawn from the market. The cancellation of the sale licences means the facility will not be permitted to continue the sale and distribution of drugs under the cancelled licences.
FDA Action Against Cipla Facility The regulatory action includes:
Cancellation of Cipla’s drug sale licences at its Pune facility
Seizure of Reactin Plus stock worth over Rs 11 lakh
Orders for a market-wide recall of the affected product
Action over alleged packaging, storage and distribution violations
The FDA’s move is aimed at preventing the circulation of products that may not have been handled in accordance with regulatory requirements.
Reactin Plus Recall Ordered
The Maharashtra FDA has advised that the affected Reactin Plus stock be removed from the supply chain and returned as part of the recall process. Pharmacies, distributors and other stakeholders have been directed to comply with the regulator’s instructions.
The development comes as drug regulators continue to tighten inspections and enforcement to ensure that medicines meet prescribed standards for packaging, storage and distribution.
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