Regulatory Updates
Sep 28, 2026•1 min read
Korea Korus hit with 1‑month manufacturing suspension over missing post‑marketing safety test
Korea Korus was ordered to halt production of its export‑only recombinant human erythropoietin product for one month after failing to conduct required post‑marketing safety studies.
Regulatory Updates
Sep 24, 2026•1 min read
MFDS reviews K‑NASS system to strengthen monitoring of medical narcotics misuse
The Korean Ministry of Food and Drug Safety inspected the pilot K‑NASS system, aiming to detect misuse and illegal distribution of medical narcotics more rapidly.
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Regulatory Updates
Sep 23, 2026•1 min read
Health Canada Alert: IMAAVY Lots May Contain Glass Particles
Health Canada warns that IMAAVY solution lots JNYJ1202 and JNYJ1206 may contain glass particles; recall limited to healthcare establishments.
Regulatory Updates
Sep 16, 2026•1 min read
Korea to Merge Three Drug Safety Agencies into New Korean Pharmaceutical Safety Agency
The government plans to consolidate the Korean Rare Essential Medicines Center, the Pharmaceutical Safety Management Agency and the Vaccine Safety Technology Support Center under a new Korean Pharmaceutical Safety Agency.
Regulatory Updates
Sep 10, 2026•1 min read
Teva Canada Recalls Novo‑Gesic Forte 500 mg Acetaminophen Over Potential Foreign Material
Teva Canada is recalling a lot of Novo‑Gesic Forte 500 mg acetaminophen tablets due to possible phenolic resin or epoxy contamination that could injure the digestive system.
Regulatory Updates
Sep 10, 2026•1 min read
Korea Pharmaceutical Safety Agency Announces 2026 Second‑Half Narcotics Handling Education
The Korea Pharmaceutical Safety Management Agency will hold a mandatory training on September 29 for dental, veterinary, pharmacy and wholesale professionals on new narcotics safety reporting and supervision rules.
Regulatory Updates
Sep 9, 2026•1 min read
MFDS adds domperidone contraindication for chromaffin‑cell tumor patients across 38 products
South Korea’s MFDS will revise labeling of 38 domperidone products to contraindicate use in patients with chromaffin‑cell tumors due to risk of severe hypertension.
Regulatory Updates
Sep 5, 2026•1 min read
Korean pharma firms recall batches of diabetes drugs and antiemetics over quality issues
Domestic manufacturers have issued voluntary recalls for certain batches of diabetes treatments and anti‑emetic tablets after detecting contamination, potency failures and impurity exceedances.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS orders recall of Il Dong Pharma's Consenvita Premium 800 tablets due to labeling omissions
The Korean MFDS has ordered a retailer‑initiated recall of Il Dong Pharmaceutical’s Consenvita Premium 800 tablets (batch RWC009, RWC010) because of missing labeling information and packaging errors.
Regulatory Updates
Aug 30, 2026•1 min read
Amgen Initiates Voluntary Recall of ~1M Bottles of Corlanor in US
Amgen voluntarily recalls about 1 million bottles of its heart‑failure drug Corlanor in the US after potential foreign particles were identified.
Regulatory Updates
Aug 30, 2026•1 min read
Apotex Apo‑Semaglutide Injection Recall Due to Incorrect Dose Display
Apotex Inc. has recalled lot 700059A of its Apo‑Semaglutide 2 mg pen after the dose window may incorrectly show a 2 mg dose, delivering 2 mg instead of the intended 0.25 mg or 0.5 mg.
Regulatory Updates
Aug 24, 2026•1 min read
Label Mix-up: Amantadine Capsules Contain Cyclobenzaprine Tablets
FDA recall (D-1035-2017) reports cartons labeled as Amantadine HCl 100 mg capsules actually contain Cyclobenzaprine HCl 5 mg tablets due to a labeling error.