Glenmark ondansetron tablets recalled for unsealed blister packs
Glenmark Pharmaceuticals discovered that blister packs containing Ondansetron 4mg orally disintegrating tablets are not fully sealed, allowing tablets to fall out. The affected product was repackaged and distributed nationwide. This applies to lot #19251311 with an expiration date of April 2027.
From the FDA notice · Read the official notice ↗ · All Glenmark recalls
What to do
- Check if you have Glenmark Ondansetron 4mg tablets, lot #19251311, expiration April 2027 (NDC 68462-157-13)
- Do not use tablets that have fallen out of the blister pack or appear loose
- Contact your pharmacy or doctor for a replacement or instructions
- Do not flush tablets down the toilet unless instructed to do so
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 96,948 packs
- Illnesses reported
- None reported
- Manufactured in
- 619 River Dr, N/A, Elmwood Park, NJ, United States
- Classification
- Class II
- Recall number
- D-0246-2026
In the FDA's words
- Description
- 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 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. Lot #: 19251311, Exp Date April 2027 Distribution: Nationwide within the United States Affected quantity: 96,948 packs
- 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.
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