FDA-Drug2026-01-07Class II
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Glenmark Pharmaceuticals Inc., USA
Hazard
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Sold states
Nationwide within the United States
Affected count
96,948 packs
Manufactured in
619 River Dr, N/A, Elmwood Park, NJ, United States
Products
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2026Don't want to check this manually?
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