Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
USProduct label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Recalling Firm: Rising Pharma Holding, Inc.
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Product Description & Identification
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Additional Source Details
| Field | Value |
|---|---|
| City | East Brunswick |
| State | NJ |
| Openfda › Nui › 1 | N0000000236 |
| Openfda › Nui › 2 | N0000175558 |
| Openfda › Unii | YF1K15M17Y |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 313209 |
| Openfda › Rxcui › 2 | 313210 |
| Openfda › Rxcui › 3 | 313211 |
| Openfda › Rxcui › 4 | 317160 |
| Openfda › Rxcui › 5 | 700883 |
| Openfda › Rxcui › 6 | 700885 |
| Openfda › Spl id | b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5 |
| Openfda › Brand name | TEMOZOLOMIDE |
| Openfda › Spl set id | 70996a9d-4a4f-4ed1-ab07-130486aa14ab |
| Openfda › Package ndc › 1 | 16571-816-51 |
| Openfda › Package ndc › 2 | 16571-816-02 |
| Openfda › Package ndc › 3 | 16571-816-41 |
| Openfda › Package ndc › 4 | 16571-817-51 |
| Openfda › Package ndc › 5 | 16571-817-02 |
| Openfda › Package ndc › 6 | 16571-817-41 |
| Openfda › Package ndc › 7 | 16571-818-51 |
| Openfda › Package ndc › 8 | 16571-818-02 |
| Openfda › Package ndc › 9 | 16571-818-41 |
| Openfda › Package ndc › 10 | 16571-819-51 |
| Openfda › Package ndc › 11 | 16571-819-02 |
| Openfda › Package ndc › 12 | 16571-819-41 |
| Openfda › Package ndc › 13 | 16571-820-51 |
| Openfda › Package ndc › 14 | 16571-820-02 |
| Openfda › Package ndc › 15 | 16571-820-41 |
| Openfda › Package ndc › 16 | 16571-821-51 |
| Openfda › Package ndc › 17 | 16571-821-02 |
| Openfda › Product ndc › 1 | 16571-816 |
| Openfda › Product ndc › 2 | 16571-817 |
| Openfda › Product ndc › 3 | 16571-818 |
| Openfda › Product ndc › 4 | 16571-819 |
| Openfda › Product ndc › 5 | 16571-820 |
| Openfda › Product ndc › 6 | 16571-821 |
| Openfda › Generic name | TEMOZOLOMIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | TEMOZOLOMIDE |
| Openfda › Pharm class epc | Alkylating Drug [EPC] |
| Openfda › Pharm class moa | Alkylating Activity [MoA] |
| Openfda › Manufacturer name | Rising Pharma Holdings, Inc. |
| Openfda › Application number | ANDA206309 |
| Openfda › Is original packager | true |
| Event id | 98523 |
| Address 1 | 2 Tower Center Blvd Ste 1401 |
| Address 2 | N/A |
| Code info | Lot #: 1TM0524003A, Exp. Date 09/2026. |
| Postal code | 08816-1149 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 1200 bottles |
| Reason for recall | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260303 |
| Initial firm notification | Letter |
| Center classification date | 20260304 |
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Overview
- Recalling FirmRising Pharma Holding, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the U.S
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🚨 SAFETY ALERT: Rising Pharma Holding, Inc. - Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51. Check if your household is affected: https://therecallfile.com/recalls/product-label-temozolomide-capsules-5mg-packaged-in-5-capsule-bottles/FDA-D-0384-2026
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