ChemLifeIntel/Companies/QuVa Pharma, Inc.

QuVa Pharma, Inc.

HIGH RISKHQ: — · Private · Founded —

LISTINGPrivateFOUNDED0

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ACTIVE REGULATORY RISK0 active regulatory actions on record · HQ · monitored across 3 manufacturing sites

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INTELLIGENCE

Showing 2 of 2 briefs on QuVa Pharma, Inc.

REGULATORY INTELLIGENCE·Recall

QuVa Pharma Initiates Class II Recall for 75,885 R.E.C.K. Syringes Due to Particulate Matter

QuVa Pharma, Inc. has initiated a U.S. nationwide Class II recall for 75,885 syringes of its compounded R.E.C.K. solution from its Sugar Land, TX facility. This voluntary action, prompted by particulate matter, impacts periarticular pain management. Procurement and regulatory teams must assess supply chain vulnerabilities and reinforce quality assurance protocols for compounded injectables, given the critical nature of such products.

90-Day Activity

QuVa Pharma,

PSPriya Subramaniam· Intelligence Analyst

2025-11-05

REGULATORY INTELLIGENCE·Recall

QuVa Pharma Faces FDA Class II Recall for Sterility Issues in Compounded Fentanyl/Bupivacaine Injectable

QuVa Pharma, Inc. has initiated a U.S. nationwide Class II recall for 2,310 cassettes of its compounded fentaNYL Citrate PF / Bupivacaine HCl injection from its Sugar Land, TX facility. The recall, effective March 6, 2025, stems from a critical lack of assurance of sterility, posing significant patient safety risks and demanding immediate attention from procurement and regulatory teams.

90-Day Activity

QuVa Pharma,

PSPriya Subramaniam· Intelligence Analyst

2025-04-02