Microbiology

Centric Compounding Recalls Six Injectable Lots for Elevated Endotoxin

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Centric Compounding voluntarily recalled six lots of compounded Glutathione 200 mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable products to the consumer level after finding that they were compounded with Glutathione API containing elevated endotoxin levels. The affected products are 30 mL multidose vials distributed nationwide to patients and prescribers. The company reported nine accounts of symptoms including fever, chills, chest pain, nausea/vomiting, headache, and/or malaise. It warned that injectable products with elevated endotoxin could cause serious events, including hypotension, inflammatory reactions, anaphylactic shock, and death. Customers are being notified, replacements arranged, and consumers instructed to stop using and discard affected vials.

FDA Warning Letter: Reliance Life Sciences cited for data integrity and aseptic processing deficiencies

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FDA’s February 19–27, 2026 inspection of Reliance Life Sciences’ Navi Mumbai drug facility identified significant CGMP violations involving laboratory data, sterile manufacturing, and quality oversight. FDA found environmental monitoring and other microbiology samples recorded as collected and incubated even though plates were absent and analysts confirmed the samples were not collected. LIMS calculations omitted required dilution factors, while electronic integrity-testing files lacked unique names and were overwritten; testing was also not performed for one plant. FDA said these deficiencies created a risk of underreported microbial findings and unreliable batch-release evidence. In aseptic operations, investigators observed operators blocking unidirectional airflow over critical locations and not discarding potentially compromised vials. FDA also observed deteriorated or damaged manufacturing areas or components, excess sealant near HEPA filters, nonsterile wipes used for cleaning, and standing water and staining near pipelines. FDA deemed the firm’s responses insufficient, citing incomplete remediation detail, traceability, oversight, and timelines. The company agreed to recall all sterile drugs and suspend U.S.-market production; FDA later placed its drugs on Import Alert 66-40.

International regulators assess recombinant endotoxins testing protocol

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FDA states that, through the International Coalition of Medicines Regulatory Authorities Collaborative Assessment Pilot, it and regulators from Australia, Canada, Japan, Switzerland, and the European Medicines Agency jointly assessed a recombinant endotoxins testing approach for biological products. The method is an alternative to the horseshoe crab blood-dependent Limulus Amebocyte Lysate test. The submission used a Post-Approval Change Management Protocol covering several biological products across multiple therapy areas. The European Medicines Agency led the review, and the PACMP was approved in June 2026, with participating authorities reaching aligned decisions within days. FDA says the pilot coordinates questions and reviews while preserving independent decisions, aiming to improve consistency, reduce duplication, and support timely access.