Par Health Recalls Two Brevital Sodium Lots for Cellulose Particulate Matter

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Par Health announced a voluntary nationwide recall to the hospital level of two lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) after particulate matter identified as cellulose was found. The affected lots are 86930, expiring February 2028, and 88623, expiring April 2028; they were distributed to wholesalers nationwide between July 8, 2025, and May 11, 2026. Par said use could cause life-threatening vascular consequences, although it had received no related adverse-event reports. Wholesalers and hospital pharmacies were instructed to stop use and distribution immediately, notify downstream accounts, and return inventory through Inmar. FDA posted the company announcement and noted that posting does not constitute endorsement.

FDA Finalizes Guidance on Postapproval Manufacturing Changes for Biosimilars

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FDA announced the availability of final industry guidance titled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.” The question-and-answer guidance addresses commonly asked questions from applicants and other interested parties about postapproval manufacturing changes to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act. It finalizes the draft guidance with the same title issued on July 23, 2024. The guidance was issued by FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research under docket FDA-2024-D-2581. The source identifies it as Final Level 1 Guidance.

EU GMP Non-Compliance (4 reports published for the same company- see previous posts): Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – inadequate OOS and aseptic controls

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Following inspections on 10–12 February and 22–23 April 2026, the Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant. The NCA recorded one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: multiple batches of registered finished products were released despite moisture or assay results outside specified limits, and an ATMP was released despite a failed in-process sterility test. The OOS procedure could permit certification and release without thorough investigation or sufficient justification. Major findings included inadequate aseptic controls, contamination control strategy, process simulations, microbiological investigation and trending, cleanroom behaviour and gowning. Weaknesses also affected the PQS, deviations, CAPA, change control, complaints, self-inspection, PQRs, computerized system validation, data integrity and documentation. The NCA’s stated action was withdrawal of four GMP certificates covering Plesmanlaan and Louwesweg. An unscheduled re-inspection is planned based on the company’s action plan. For the M22BOL study, the NCA described limited impact and left decisions to concerned Member States; no implemented suspension was reported.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – Inadequate OOS controls and release after failing results

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The Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant after inspections on 10–12 February and 22–23 April 2026. The conclusion was based on one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: several registered finished-product batches were released despite moisture-content or assay results outside specified limits, and an investigational ATMP was released after a failed in-process sterility test. The OOS procedure could also permit certification and release without thorough investigation or sufficient justification. Major findings covered incomplete aseptic controls and contamination strategy, inadequate process simulations, weak microbiological investigation and trending, operator and gowning practices, deficiencies across the pharmaceutical quality system, inadequate computerized-system validation and data integrity, and poor documentation practices. The Inspectorate withdrew current GMP certificates, including certificates covering Louwesweg 6. A re-inspection, not yet scheduled, is planned against the company’s action plan; a new certificate would follow a positive outcome. For study EU CT 2023-505039-11-00, the NCA considered impact limited and left market decisions to concerned Member States.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – Inadequate OOS handling and aseptic controls

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Following inspections on February 10–12 and April 22–23, 2026, the Netherlands Health and Youth Care Inspectorate concluded that the hospital pharmacy was GMP non-compliant, citing one critical, seven major and fourteen other deficiencies. The critical deficiency concerned inadequate OOS handling: registered finished-product batches were released outside moisture or assay limits, and an ATMP was released despite a failed in-process sterility test. Major findings covered incomplete contamination controls, inadequate aseptic process simulations, deficient microbiological investigation and trending, poor cleanroom behaviour and gowning, and weaknesses in the pharmaceutical quality system, computerized system validation, data integrity and documentation. The NCA stated withdrawal of four current GMP certificates, including certificates for Plesmanlaan 121. A reinspection is planned but not yet scheduled; successful reinspection would support a new certificate and withdrawal of the non-compliance statement. For trial EU CT 2023-505039-11-00, the NCA assessed the impact as limited and left market decisions to concerned Member States; no trial suspension was reported.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – inadequate OOS handling allowed release of non-compliant batches

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Following its 2026 inspection, the Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant for sterile, non-sterile, biological and packaging operations. The NCA recorded one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: several registered finished-product batches were released outside moisture or assay limits, and an ATMP was released after a failed in-process sterility test; ambiguous procedures could permit certification without adequate investigation or justification. Major findings covered incomplete aseptic controls and contamination strategy, inadequate process simulations, weak microbiological test design, investigation and trending, operator and gowning deficiencies, an insufficient pharmaceutical quality system, inadequate computerized-system validation and data integrity, and poor documentation practices. For the sole EU-facing study, DS-8201a relabeling and repackaging, the NCA considered impact limited but said systemic deficiencies could affect it. It left market decisions to concerned Member States; no trial suspension was stated. The NCA withdrew four GMP certificates and plans an as-yet-unscheduled re-inspection. Positive re-inspection would permit recertification and withdrawal of the statement.

EU GMP Non-Compliance: Ocb Pharmaceutical S.R.L. – relabelling and distribution obscured bismuth subsalicylate supply-chain traceability

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Following an inspection ending 27 August 2026, the Spanish NCA identified nine deficiencies: one critical and eight major. The critical deficiency concerned repackaging and relabelling bismuth subsalicylate from a Chinese manufacturer operating outside the EU GMP framework. OCB assigned new batch numbers, copied supplier results into certificates of analysis, replaced or removed original labels, and distributed material without adequately preserving manufacturer identity and supply-chain traceability. Major deficiencies affected investigations, CAPA, risk management, data integrity, personnel qualification, materials traceability, contamination controls, cleaning, facilities, documentation and quality oversight. The NCA temporarily suspended all API and intermediate manufacturing at Canovelles and suspended distribution and sale of material manufactured, repackaged or relabelled there, pending correction and verification through reinspection. No recall was considered necessary because no specific defects in marketed batches were detected. The NCA said suspension of the site’s bismuth subnitrate CEP should be considered. It also withdrew the current GMP certificate and recommended justified testing by customers, alternative qualified sources, and exclusion from new or ongoing applications while the statement remains in force.

FDA Terminates Haleon Robitussin Recall for Microbial Contamination

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FDA posted Haleon’s January 24, 2024 announcement of a voluntary consumer-level recall of eight lots of Robitussin Honey CF Max Day Adult and Nighttime Adult cough syrups because of microbial contamination. Haleon stated that affected products could potentially cause severe or life-threatening infections in immunocompromised individuals, while infections requiring medical intervention could not be completely ruled out in other consumers. No related adverse events had been reported at the time of the announcement. Haleon notified distributors and customers, provided return instructions, and advised consumers to stop use immediately. The FDA page now states that the recall has been completed and FDA has terminated it.

FDA Warning Letter: Pine Pharmaceuticals cited for aseptic control, investigation, and validation deficiencies

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FDA inspected Pine Pharmaceuticals’ outsourcing facility from November 4–14, 2025, and found evidence of insanitary conditions and CGMP violations in production of drugs intended to be sterile. Operators did not sanitize materials, equipment, hands, or sleeves appropriately when moving from the ISO 7 area into the ISO 5 critical area. FDA also found that routine environmental monitoring did not cover manually handled, high-touch staging trays with a difficult-to-clean design. The letter cites inadequate investigations, deficient aseptic and sterilization process procedures and validation, inadequate personnel qualification, and deficient yield and reject-rate controls. FDA said particulate defects could bypass investigation triggers, while undefined “cosmetic” defects could be returned to batches. Responses were considered unsupported or deficient, including failure to establish root causes for particulates and recurring closure or inspection defects, reliance on reinspection and retrospective risk assessments, and incomplete CAPAs. FDA also found inadequate change control and requalification of visual inspectors, incomplete reject-rate corrections, and undefined, operator-dependent mixing parameters without a detailed validation plan.

FDA Warning Letter: Inadequate Testing, Process Validation, and Quality Unit Oversight at TCI BioCosme

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FDA states that its March 2026 inspection identified significant CGMP violations in the manufacture of OTC drug products. The firm released U.S.-market batches without finished-product assay testing for the active ingredient, and its quality system did not ensure that required tests were identified, documented, and completed. FDA also observed inadequate identity testing of incoming APIs and raw materials, reliance on supplier certificates of analysis without establishing their reliability, and failure to perform applicable USP monograph tests. Manufacturing processes were not adequately validated: a validated process differed from the batch record, and validation for one product was used to support another product with a different process. Qualification and monitoring of a component used in products and equipment cleaning lacked specified chemical and microbial testing and defined microbial limits. FDA further cited inadequate quality unit oversight, including undocumented process-parameter changes, deficient batch records, and the absence of a written stability testing program. FDA found the firm’s Form FDA 483 response inadequate because it lacked sufficient supporting documentation and evidence of corrective actions.