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
USOndansetron 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
Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall / 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.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Elmwood Park |
| State | NJ |
| Openfda › Nui › 1 | N0000175817 |
| Openfda › Nui › 2 | N0000175818 |
| Openfda › Upc › 1 | 0368462157138 |
| Openfda › Upc › 2 | 0368462106303 |
| Openfda › Upc › 3 | 0368462105306 |
| Openfda › Upc › 4 | 0368462158111 |
| Openfda › Unii › 1 | 4AF302ESOS |
| Openfda › Unii › 2 | NMH84OZK2B |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 104894 |
| Openfda › Rxcui › 2 | 198052 |
| Openfda › Rxcui › 3 | 312086 |
| Openfda › Rxcui › 4 | 312087 |
| Openfda › Spl id | 32177a6a-8c35-4e1c-b7f5-7376b1c1316a |
| Openfda › Brand name | ONDANSETRON |
| Openfda › Spl set id | eee5217a-eba8-463a-812d-bf3c66f0934f |
| Openfda › Package ndc › 1 | 68462-105-33 |
| Openfda › Package ndc › 2 | 68462-105-30 |
| Openfda › Package ndc › 3 | 68462-106-33 |
| Openfda › Package ndc › 4 | 68462-106-30 |
| Openfda › Package ndc › 5 | 68462-157-13 |
| Openfda › Package ndc › 6 | 68462-158-11 |
| Openfda › Package ndc › 7 | 68462-158-13 |
| Openfda › Product ndc › 1 | 68462-105 |
| Openfda › Product ndc › 2 | 68462-106 |
| Openfda › Product ndc › 3 | 68462-157 |
| Openfda › Product ndc › 4 | 68462-158 |
| Openfda › Generic name | ONDANSETRON |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | ONDANSETRON HYDROCHLORIDE |
| Openfda › Pharm class epc | Serotonin-3 Receptor Antagonist [EPC] |
| Openfda › Pharm class moa | Serotonin 3 Receptor Antagonists [MoA] |
| Openfda › Manufacturer name | Glenmark Pharmaceuticals Inc., USA |
| Openfda › Application number | ANDA077535 |
| Openfda › Is original packager | true |
| Event id | 98233 |
| Address 1 | 619 River Dr |
| Address 2 | N/A |
| Code info | Lot #: 19251311, Exp Date April 2027 |
| Postal code | 07407-1317 |
| Report date | 20260107 |
| Product type | Drugs |
| Product quantity | 96,948 packs |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251230 |
| Initial firm notification | Letter |
| Center classification date | 20251231 |
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Overview
- Recalling FirmGlenmark Pharmaceuticals Inc., USA
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States
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🚨 SAFETY ALERT: Glenmark Pharmaceuticals Inc., USA - 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 Check if your household is affected: https://therecallfile.com/recalls/ondansetron-orally-disintegrating-tablets-usp-4mg-30-tablets-3-blister/FDA-D-0246-2026
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