August 28, 2025, AquaStar (USA) Corp of Seattle, WA is recalling approximately 26,460 packages of Cocktail Shrimp 6oz (see photo), imported from Indonesia, because they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with cesium-137 (Cs-1
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Hetero Labs Limited, Unit-IX – 09/26/2025
Hetero Labs Limited, Unit-IX – 09/26/2025. Country: India. Record Type: 483Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act
This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.Commissioner’s National Priority Voucher (CNPV) Pilot Program
FDA Commissioner’s National Priority Voucher Program. The Commissioner’s National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue
Dropping or severely jarring Alaris Pumps may damage critical pump components. Do not use dropped or jarred devices until thoroughly inspected and testedSanofi S.p.A. – 05/22/2023
Sanofi S.p.A. – 05/22/2023. Country: Italy. Record Type: 483GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination
Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p
