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Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg

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INTELLIGENCE

Showing 2 of 2 briefs for Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg
REGULATORY INTELLIGENCE·Recall

Glenmark Pharmaceuticals Faces Class II Recall for Ondansetron ODTs Over Packaging Defects

Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall for 96,948 packs of Ondansetron Orally Disintegrating Tablets, 4mg, due to defective, unsealed blister packs. This nationwide recall, stemming from a product manufactured in India, highlights critical supply chain vulnerabilities and quality control challenges for procurement and regulatory teams managing essential antiemetic supplies.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2026-01-07
REGULATORY INTELLIGENCE·Recall

Endo USA, Inc. Faces FDA Class I Recall for Clonazepam ODT Due to Critical Labeling Error

Endo USA, Inc. has initiated a voluntary Class I recall for 8,029 cartons of Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg. This critical action stems from a labeling error where cartons displayed incorrect strength, posing significant patient safety risks. Procurement and regulatory teams must assess immediate supply chain disruptions and scrutinize quality control protocols for similar products.

90-Day Activity
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2025-01-15 Recall