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PharmExpert Global

Meropenem leaflet errors and IMAAVY glass-particle recall

  • 24-09-2026
  • Posted by: Eldaniz Hasanov
  • Category: Regulatory Updates
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On 24 September 2026, PharmExpert reviewed two new official medicine-safety communications: an MHRA notification about errors in the patient leaflet for Meropenem 1000 mg and a Health Canada recall of two IMAAVY lots because they may contain glass particles.

MHRA: Meropenem 1000 mg, EL(26)A/39

On 23 September, the MHRA issued Class 4 Medicines Defect Notification EL(26)A/39 (DMRC-40832810) for B. Braun Meropenem 1000 mg powder and solvent for solution for infusion, PL 03551/0167. It covers lots 25J00360, 25J01305, 25J02333, 25J02595, 25J02331, 25J02332 and 25J02335.

The leaflet states sodium as 245 mg (12.3%) instead of 290 mg (14.5%), and section 6 states 500 mg meropenem instead of 1000 mg. The label and SmPC are correct. According to the MHRA, the issue does not affect formulation quality or efficacy. Because the medicine is considered critical, supply continues; healthcare professionals should use the corrected information, particularly for new patients. Patients should not stop treatment without speaking to a healthcare professional.

Official source: MHRA EL(26)A/39

Health Canada: IMAAVY, RA-82660

Health Canada published a Type II recall on 23 September for IMAAVY solution 300 mg/1.62 mL, DIN 02563509, lots JNYJ1202 and JNYJ1206, supplied by Janssen Inc. The lots may contain glass particles. The recall is at healthcare-establishment depth with national distribution. Health Canada advises checking whether product is affected and consulting a healthcare provider with health concerns. The page’s technical modification field shows 21 September, while the card gives an original publication date of 23 September; the delta is based on the card’s appearance.

Official source: Health Canada RA-82660

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official MHRA communication dated 23 September 2026 and Health Canada communication dated 23 September 2026, and current as of 24 September 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturers/marketing authorisation holders or a quality concern affecting either company’s entire product portfolio. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.