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Glenmark Pharmaceuticals Inc., USA: Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glen

DrugsSource: FDA (drug) · Date: 2026-01-07

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Glenmark Pharmaceuticals Inc., USA
Product
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
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2025-12-30
Code info
Lot #: 19251311, Exp Date April 2027
Product quantity
96,948 packs
Voluntary mandated
Voluntary: Firm initiated
City
Elmwood Park
State
NJ
Country
United States
Event id
98233
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