GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
Par Health USA's argatroban injection is subject to an ongoing nationwide US recall, number D-0083-2027, after particulate matter was identified in the product solution.
The FDA's enforcement report lists an ongoing nationwide US recall of AvKARE's amitriptyline hydrochloride after the product failed dissolution specifications.
An ongoing nationwide US recall, numbered D-0084-2027, concerns a glutathione injection product named in the FDA enforcement report as Glutathione-L (Greenwich Rx).
Shenzhen Techdow Pharmaceutical's heparin sodium injection recall, numbered D-0050-2027, is listed as ongoing and covers nationwide distribution in the US.
FDA's enforcement report lists a Class II recall of Hikma's Abirtega (abiraterone acetate) USP, with distribution nationwide and the recall still ongoing.
The recall, numbered D-0079-2027, covers cinacalcet tablets from Strides Pharma Inc, is ongoing and was distributed across the US.
Pritam International Private Limited's BB (Brush Buddies) Cavity Protection is subject to an ongoing nationwide US recall, classified Class II, citing deviations from current good manufacturing practice.
Pritam International Private Limited's BB (Brush Buddies) Advanced Whitening is subject to an ongoing nationwide US recall, classified Class II for current good manufacturing practice deviations.
A Type II recall covers one kit lot of bioMérieux's BIOFIRE BCID2 Panel after complaints of false negatives, linked to unintended movement of pouch chemistry.
Agilent's electronic instructions for three lots wrongly give tissue-section thickness and slide-storage temperature, after hyphens were lost in a formatting change, Health Canada reports.
Siemens Healthineers is rolling out service pack NX VA60A-SP04, a full-installation bug fix, for Magnetom scanners under a Type II recall recorded by Health Canada.
Ravimiamet says a low price and promised delivery do not make a foreign web shop authorised to sell medicines, and customs detentions of illicit medicines remain high.
Germany's medicines and devices authority has listed an urgent field safety notice for an Inova in vitro diagnostic reagent, with the details contained only in the manufacturer's advisory.
Germany's medicines and devices regulator has listed a manufacturer advisory on MOSAIQ, but the specific issue and required actions appear only in Elekta's attached notice.
The German regulator has listed a manufacturer field safety notice for an in-vitro diagnostic antibody product, but the public entry gives no detail on the problem or required action.
The German regulator has posted a field safety notice from TRACOE medical GmbH for its TRACOE vario device, but the listing refers readers to the manufacturer's attached Advisory Notice for details.
Germany's regulator has posted a manufacturer advisory on the eMAG in-vitro diagnostic system; the specifics of the issue sit in an attached PDF.
BfArM has published Beckman Coulter's notice covering LabPro V5.0 Maintenance Update 1 with Panel Update 09, though the issue and required actions are only in the enclosed Advisory Notice.
Germany's federal medicines and devices authority has listed an urgent field safety notice from Getinge Disinfection AB, but the details sit in the manufacturer's attached advisory document.
The German regulator has posted an urgent field safety notice from EKF-diagnostic GmbH on a reagent for Biosen analysers; the details sit in the manufacturer's attached advisory.
The Danish Medicines Agency says Gilead Sciences Sweden AB will stop marketing Tybost (cobicistat) 150 mg tablets for commercial reasons, with the expected period starting at the end of December 2026.
The Danish Medicines Agency expects UCB Nordic's lacosamide 100 mg film-coated tablets to be affected from early November 2026 until early February 2027, citing increased sales and demand.
The Danish Medicines Agency says Thea Nordic AB's latanoprost/timolol eye drops are affected by production problems, with disruption expected from late September to early December 2026.
The Danish Medicines Agency says Euthasol vet. 400 mg/ml is affected by production problems, with disruption expected from late September to early November 2026.
The agency's weekly list for 19 to 23 October 2026 covers notices from 14 manufacturers, among them glucose monitoring, infusion pump, defibrillator and X-ray equipment.
Germany's regulator has listed a manufacturer advisory on the Rotaflow Console, but the public entry does not describe the fault or the corrective actions required.
The Danish Medicines Agency has surveyed public behaviour and attitudes towards online medicine purchases, finding sensible habits but limited knowledge of the sales rules.
Austria's BASG has issued an updated safety notice naming Italian municipalities with confirmed locally acquired dengue cases, asking blood services to take them into account at donor selection.
BASG reports a pharmacy-level recall of one Viatris Austria batch of vitamin D3 and calcium chewable tablets because several serial numbers were never uploaded.
CBER says Beaute Bounty's website markets embryonic stem cell and placenta-derived products with disease claims, without the approved biologics licence the agency requires.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.