GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
Kwame Raoul says the defendant took nearly $10,000 from Illinois for services never provided, in a case linked to a nationwide healthcare fraud enforcement action.
Czech regulator SÚKL has told distributors and healthcare facilities to withdraw a specified batch of Nitromint 2.6 mg modified-release tablets; patients need not return packs.
The Czech regulator has told distributors and healthcare facilities to withdraw a specified batch of Betadine 30 g ointment; patients are not asked to return packs.
The Czech regulator has published a marketing authorisation holder's letter on a quality defect in Caelyx pegylated liposomal 2 mg/ml, 1 x 25 ml, involving a stopper and closure that could come loose.
Italy's medicines agency has published a quality DHPC after reports that the aluminium ferrule on some Caelyx/Doxil 50 mg/25 mL vials was improperly sealed, risking sterility and operator exposure.
VB Spine reports ES2 Spinal System Nitinol K-Wire Blunt devices have broken during removal from patients, with 16 complaints worldwide so far, according to Dutch inspectorate IGJ.
The agreement covers work at Celularity's New Jersey site, but supply to US compounders depends on FDA adding the peptides to its bulk drug substances list.
Olympus Winter & Ibe says 19 further monopolar and bipolar HF cable models may share a defect linked to a minor burn; the Dutch inspectorate IGJ has published the notice.
The Czech regulator's quality defects department has told distributors and healthcare facilities to withdraw a specified batch of Mynzepli 40 mg/ml solution for injection; patients need not return packs.
The manufacturer has voluntarily withdrawn the affected batches, saying the particles pose an unacceptable risk to the safety and performance of the syringes, according to the Dutch inspectorate IGJ.
Germany's regulator has posted a manufacturer notice on the ENT device but its own entry gives no detail on the problem, affected units or actions required.
Germany's regulator has listed an urgent field safety notice for two TruSystem surgical devices, but the hazard and required actions appear only in the manufacturer's attached advisory.
Germany's regulator has published a manufacturer advisory covering Sebia's HYDRAGEL 7 ISO-PAL and HYDRAGEL 15 ISO-PAL, but the public listing gives no detail on the issue.
France's regulator has withdrawn one batch each of Biogaran's Afiveg and Advanz Pharma's Mynzepli after a syringe flaw that could cause needle movement or an incomplete intravitreal dose.
BASG reports a pharmacy-level recall of one Mynzepli 40 mg/ml batch after the marketing authorisation holder identified faulty grip aids on the syringes.
Czech regulator SÚKL has told distributors and healthcare facilities to withdraw a specified batch of Mynezpli 40 mg/ml solution for injection; patients need not return packs.
Class 2 recall EL(26)A/45 targets pharmacy and wholesaler stock after a single complaint of mixed strengths inside a sealed pack.
The IGJ, acting for the health minister, has imposed an administrative fine on Mediahuis NRC B.V.; the published notice does not state the violation or the amount.
EOF has announced the recall of batches 467504, 477651 and 484536 of Pedmarqsi infusion solution; the available notice does not give a reason or recall level.
The Czech regulator has told distributors and healthcare facilities to withdraw specified batches of Mitomycin Accord 20 mg powder for solution; patients need not return packs.
Advanz Pharma is recalling two batches of Mynzepli 40 mg/mL pre-filled syringes as a precaution, after a small variation in finger grip size was found that could affect administration.
Grifols Deutschland has voluntarily recalled batch G04L046403 of Gamunex 10% infusion solution, according to an information letter published by the Paul-Ehrlich-Institut.
The German regulator has posted a manufacturer safety notice for a femoral knee fusion nail, but the defect, affected lots and required actions appear only in an attached PDF.
Germany's regulator has listed an Urgent Field Safety Notice from Abbott Diabetes Care Ltd. UK for two glucose-monitoring apps, but the entry itself gives no details of the issue.
Pritam International Private Limited's Brush Buddies recall, numbered D-0063-2027, is ongoing and covers US nationwide distribution, according to the FDA enforcement report.
FDA's enforcement report lists a Class II recall of Pfizer's levothyroxine sodium tablets after an out-of-specification assay result, with distribution across the US and Puerto Rico.
Right Value Drug Stores LLC's nationwide recall of testosterone cypionate, numbered D-0070-2027, is classed as Class II and remains ongoing, according to the FDA enforcement report.
A nationwide US recall involving Pritam International Private Limited, listed under number D-0069-2027, has been classified Class II for current good manufacturing practice deviations and remains ongoing.
Recall D-0045-2027 covers amlodipine and olmesartan medoxomil tablets distributed nationwide in the US and remains ongoing, according to the FDA enforcement report.
The enforcement report entry, recall D-0059-2027, is ongoing and covers US nationwide distribution of a drug product from India-based Pritam International Private Limited.
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.