Maria A. Carballosa, M.D. – 720805 – 12/12/2025
In Vivo Bioavailability-Bioequivalence Studies – Clinical
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Revive Rx LLC dba Revive Rx Pharmacy – 709509 – 09/22/2025
Compounding Pharmacy/Adulterated Drug Products -
Medinatura New Mexico, Inc. – 716025 – 12/10/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Guangdong Renhe Guozhuang Biotechnology Co., Ltd. – 719045 – 12/16/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Darmerica, LLC – 716152 – 12/08/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded -
FDA approves drug to improve functional capacity and symptoms in adults with rare inherited heart condition
The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. -
SV Labs Corporation – 716503 – 12/09/2025
CGMP/Finished Pharmaceuticals/Adulterated -
How medicines affect gut bacteria could inform safer, more effective use
Understanding gut microbiome interactions with medicines could help explain differences in how people respond to treatment and build on existing medicine safety knowledge to support safer, more effective prescribing in the future.
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Troemner Roemner Farm Issues Allergy Alert on Undeclared Milk, Wheat, and Soy in Pfeffernusse Cookies
Troemner Farm of Atlantic Mine, MI is recalling Troemner Family Farm branded 6 oz and 12 oz Pfeffernusse Cookies, because it may contain undeclared milk, wheat, and soy. People who have an allergy or severe sensitivity to milk, wheat, or soy run the risk of serious or life-threatening allergic react -
Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo), Due to Elevated Lead Levels
Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) to the consumer level. In test conducted by the Food and Drug Administration the product has been found to contain lead at levels up to 11,100 -
Guidance: MMRV Vaccine Factsheet – Information for Parents and Caregivers
The MMRV vaccine will become part of the routine childhood immunisation schedule in the UK from 1 January 2026.