Medicine and device safety review — 3 November 2026
- 03-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
Ten verified official communications: medicine precautions, selected safety-related recalls, diagnostic-device corrections and pharmacovigilance education. The communications were published on 30 October and 2 November and reviewed on 3 November. Local communications about already known issues are distinguished from new global signals.
Mirapex: updated precautions for safe use
Roszdravnadzor · Card date: 2026-11-02 · Document: 01И-1276/26; 4479/Р/2026 · Manufacturer letter date: 2026-10-23
Roszdravnadzor published changes to Mirapex product information. These address the minimum effective dose for restless legs syndrome, somnolence and driving precautions, regular monitoring for impulse-control disorders, risk factors for dopamine agonist withdrawal syndrome, and augmentation with dose increases. The manufacturer letter is dated 23 October; the regulator letter is dated 2 November.
Albumin: batch Н1660925 recalled following pyrogenicity nonconformity
Roszdravnadzor · Card date: 2026-11-02 · Document: 01И-1273/26 · Primary document date: 2026-11-02
Roszdravnadzor reports that Microgen is recalling batch Н1660925 of Albumin 20%, 100 mL solution for infusion. Stability testing identified nonconformity with the pyrogenicity specification. The letter calls for withdrawal of this batch and reporting of the measures taken. It does not describe adverse-reaction cases.
VITROS A1c: French recall communication on falsely elevated results
ANSM · Card date: 2026-11-02 · Document: R2631860; CL2026-224a_EU_FR · Primary document date: 2026-10-23
ANSM published QuidelOrtho’s notice on falsely elevated HbA1c results that may lead to incorrect diagnosis or patient management. Use must stop and stock must be discarded for GEN 05, 38, 42, 45, 46, 48 and 49. No action is required for expired GEN 43 and 44. As of 15 October, the manufacturer reported 58 complaints and no adverse events. This is a French communication about an already known issue.
Tosoh HLC-723GR01: mandatory syringe-unit correction
ANSM · Card date: 2026-11-02 · Document: R2631392; FA9 · Primary document date: 2026-10-19
Three analyzers, serial numbers 10364511, 10364711 and 10364811, require reinforcement of the 5 mL syringe-unit detection flag. Complete obstruction stops the analyzer without producing a result; the expected consequence is interruption or delay of testing. No incorrect results or confirmed patient harm are reported. Use may continue pending correction if operation is normal and no associated error appears. Stop the analyzer and contact Tosoh if that error occurs.
Cyclophosphamide: batch 7Z10346A recalled for particulate matter
Health Canada · Card date: 2026-11-02 · Document: RA-82896
Health Canada lists a Type I recall of batch 7Z10346A of Marcan Pharmaceuticals’ Cyclophosphamide for Injection USP, 1000 mg/vial, DIN 02560216, because of particulate matter. The recall reaches healthcare establishments. Recall questions should be directed to the recalling firm; people with health concerns should consult their healthcare provider.
CWP 800: Type I recall involving defective circuit breakers
Health Canada · Card date: 2026-11-02 · Document: RA-82900 · Recall date: 2026-10-30
Health Canada published a Type I recall of CWP 800 systems because of defective circuit breakers. The listing covers CWP 800RO2, model 115642, and CWP 800RO1, model 115641, serial numbers 83015851 and 83015856. The recall date is 30 October and publication date is 2 November. Healthcare users are directed to the manufacturer for further information. The card does not specify a clinical harm mechanism or injury cases.
Caelyx: German letter on inspecting vial integrity
BfArM · Card date: 2026-10-30 · Document: Rote-Hand-Brief; separate number not stated · Primary document date: 2026-10-30
BfArM published a German letter on closure defects in affected Caelyx 50 mg/25 mL batches: 5H020AA/5H020A, 5I021B, 5J023C and 5J023E. Inspect vials from these batches before and after removing the plastic cap; do not use visibly defective vials. Vials without visible defects may be used as intended. The letter describes sterility, infection and occupational-exposure risks, while assessing overall risk as low and reporting no related adverse events. This is a local communication about a known issue, without a recall announcement.
Respreeza: vial integrity and risk of missed doses
PEI · Card date: 2026-10-30 · Document: Rote-Hand-Brief; separate number not stated · Primary document date: 2026-10-22
PEI published a letter about Respreeza 1000 mg batch P100897449: removing Mix2Vial after reconstitution may compromise the closure, causing delayed or missed dosing and potential infection. Do not administer the product if this defect occurs; retain the vial and transfer set for investigation. Patients receiving home treatment should be informed. The letter reports 13 confirmed defects without related adverse events; the benefit–risk balance remains positive.
AEM: report suspected adverse reactions
Azerbaijan AEM · Card date: 2026-11-02 · Document: No separate document number · Primary document date: 2026-11-02
AEM joined the 2–8 November campaign and called on patients and healthcare professionals to report suspected adverse reactions. Certainty of causation is not required. The communication highlights serious symptoms, symptoms absent from the leaflet and those affecting daily life. This is pharmacovigilance education, not a new product-specific safety signal.
Kazakhstan NDDA resumes adverse reaction reporting
Kazakhstan NDDA · Card date: 2026-11-02 · Document: No separate document number
NDDA announced that reporting for medicines, medical devices and vaccines has resumed in the updated module. Previously submitted reports were migrated and do not need to be resubmitted. The transitional module operates through the end of 2026. According to the notice, from 2027 reports will be submitted through the dedicated Pharmacovigilance portal.
Official communication
· Transitional reporting module
· Pharmacovigilance portal
QPPV, LQPPV and LCPPV may use these materials when assessing local applicability and adverse-reaction reporting processes. Role names and responsibilities vary by jurisdiction.