Maharashtra FDA cancels Cipla Pune unit’s licence over Reactin Plus packaging, storage and recall lapses

FDA cancels Cipla unit's drug licence: During an inspection in June, FDA officials found that the packaging of Reactin Plus Tablets, a Schedule H prescription medicine, carried an unauthorised claim describing it as an analgesic and antipyretic.

Mumbai, August 28, 2026: The Maharashtra Food and Drug Administration has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) unit in Pune over serious irregularities related to the packaging, storage and recall of Reactin Plus Tablets, the regulator said.The FDA said in a statement issued on Friday that the cancellation came into effect on August 27, following an inspection of its main warehouse at Wadki in Pune district.The regulator had found that medicines were stored directly on the floor and flagged deficiencies in procedures for handling expired medicines.Maharashtra FDA has cancelled the C&F drug sale licence of Cipla Pharma & Life Sciences’ Pune unit over serious irregularities in the Reactin Plus Tablets case. An unauthorised advertisement and multiple storage, stock-record and recall-related violations were found during… pic.twitter.com/bTzr5MJxCI— IANS (@ians_india) August 28, 2026Irregularities In Drug PackagingDuring an inspection around June this year, officials found that the packaging of Reactin Plus tablets, a Schedule H prescription medicine, carried an unauthorised claim describing it as an "analgesic and antipyretic", the statement said.The FDA seized stock worth Rs 11.19 lakh, saying such advertising was contrary to provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.The FDA subsequently directed the company to recall the misbranded Reactin Plus Tablets from the market. However, the company didn't fully comply with the directions and required measures, the regulator stated.Storage And Record DeficienciesA subsequent inspection of the C&F unit's drug sale and distribution system found deficiencies in storage arrangements, discrepancies between purchase and sale records and actual computerised stock, and non-compliance with recall directions, according to the statement.The FDA also found discrepancies between physical stock and computerised records, medicines stored directly on the floor, inadequate pallet and rack arrangements, and deficiencies in records and procedures for handling expired medicines.FDA Orders Licence CancellationThe department issued a show-cause notice to the licence holder. After examining the company's explanation, the FDA found that the deficiencies and directions concerning the recall of Reactin Plus Tablets had not been adequately complied with.Also Watch: 'No Exemption For 5-Star Eateries In Food Safety Crackdown': FDA Chief Tukaram Mundhe At Mumbai Press ClubFDA Commissioner Tukaram Mundhe said the department would not show any leniency on issues concerning drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines."Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," he said.(Disclaimer: Except for the headline, this article has not been edited by FPJ's editorial team and is auto-generated from an agency feed.)

FDA cancels Cipla Pune units licence over Reactin Plus storage record lapses

The Maharashtra Food and Drug Administration has revoked Cipla's licenses to sell Reactin Plus Tablets due to serious violations in packaging and storage practices. Medicines were improperly stored on the floor, and the handling of expired products was inadequate. Cipla also failed to comply with the necessary recall protocols for misbranded drugs. The authorities emphasized that stringent measures will be implemented to ensure adherence to drug safety regulations.