FDA lists Class II recall of Certus Medical Satin Foam from Abc Compounding over CGMP deviations
The recall of Certus Medical Satin Foam, entered in FDA's enforcement report on 4 November 2026, is ongoing and covers nationwide US distribution.
GMP and GDP, inspections, quality-defect recalls, warning letters, data integrity and enforcement.
The recall of Certus Medical Satin Foam, entered in FDA's enforcement report on 4 November 2026, is ongoing and covers nationwide US distribution.
The US regulator's enforcement report records an ongoing, nationwide recall of 1-gallon Palm Antiseptic Hand Soap, classed as Class II and attributed to CGMP deviations.
Abc Compounding Co., Inc. is recalling PRO CHEM Fresh Start nationwide under recall D-0097-2027, which FDA classed as Class II and still ongoing.
The nationwide recall, numbered D-0100-2027, is classed as ongoing in the FDA enforcement report dated 4 November 2026.
Abc Compounding Co., Inc.'s hand soap recall, numbered D-0099-2027, is ongoing and covers nationwide US distribution, according to the FDA enforcement report.
An FDA enforcement report entry classifies the Direct Rx Lidocaine Ointment USP recall as Class II for subpotency; the recall is ongoing and covers the whole US.
Abc Compounding Co., Inc. is recalling the antiseptic wash nationwide under recall number D-0086-2027, which the FDA enforcement report shows as ongoing.
The Ritedose Corporation's nationwide US recall of Formoterol Fumarate Inhalation Solution, listed as ongoing, stems from a failed impurities/degradation specification, according to the FDA enforcement report.
An enforcement report entry records an ongoing nationwide recall of SunCoast Paper's Surgent Antiseptic Hand Soap, linked to Abc Compounding Co., Inc. and cited for CGMP deviations.
The FDA enforcement report lists an ongoing, nationwide Class II recall of metoclopramide tablets from Safecor Health, LLC, after a co-mingled tablet was identified.
Abc Compounding Co., Inc. is recalling Freshhands Premium Foamy Antibacterial Hand Soap Antiseptic nationwide, with the action classed as Class II and still ongoing.
The US regulator's enforcement report records an ongoing, nationwide Class II drug recall, numbered D-0101-2027, citing deviations from current good manufacturing practice.
The recall, numbered D-0091-2027, is ongoing and covers product distributed across the United States, according to the FDA's enforcement report.
Abc Compounding Co., Inc.'s PRO CHEM BAN AID is the subject of an ongoing, nationwide Class II drug recall citing deviations from current good manufacturing practice.
The recall, numbered D-0080-2027, is ongoing and covers distribution nationwide within the US after a product failed impurities and degradation specifications.
Macleods Pharma USA's olmesartan medoxomil recall, numbered D-0077-2027, is ongoing and covers nationwide distribution in the United States, according to the FDA enforcement report.
The ongoing nationwide US recall, numbered D-0104-2027, was listed in the FDA enforcement report dated 4 November 2026 and cites deviations from current good manufacturing practice.
The nationwide recall of Wechem Hand Guard 8/1000mL Bag, recorded as D-0103-2027, is listed as ongoing in the FDA enforcement report dated 4 November 2026.
A Type II recall covers one lot of Plateletworks Collagen Kit after internal testing found many tubes aggregated poorly, risking false suggestions of abnormal platelet function.
Nine lots of the apple-flavoured veterinary powder are affected by a defect that may compromise container closure integrity, with national distribution down to retail level.
The German regulator has posted a manufacturer notice covering the Electric 2, Rapid 2 and Scrambler 2 handbike attachments, though the hazard and required actions are not stated in the listing.
Germany's BfArM has posted a manufacturer field safety notice for Hologic's Horizon DXA bone densitometry system, but the nature of the problem is only in the attached Advisory Notice.
The Danish Medicines Agency says Teva Denmark's bendroflumethiazide and potassium chloride tablets are affected by increased demand, with only a partial delivery of 100 packs expected in early October.
Italy's medicines agency explains how companies receive paper GMP measures by registered post and points to earlier notices governing digitally signed documents and online submissions.
Germany's BfArM has published a manufacturer field safety notice for Urotech GmbH's Flexible Injection Needle, but the listing itself does not set out the problem or the required actions.
Germany's regulator has posted a Medline International France SAS field safety notice on sterile OP-Abdecktücher, but the listing itself gives no details of the defect or affected lots.
Germany's federal regulator has published a manufacturer notice on SOPHIE, but its listing does not state the issue, affected devices or required actions.
The German regulator has listed an urgent field safety notice from RAL Diagnostics for two laboratory staining instruments; details sit in the manufacturer's Advisory Notice.
DKMA says supply of Boehringer Ingelheim's romifidine veterinary injection is disrupted, with the disruption expected to last from early to mid-November 2026.
The UK regulator's weekly roundup names manufacturers including Abbott, Philips, Abiomed and Beckman Coulter, but gives no detail on the nature of the problems.
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.