Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, D…
Zydus Pharmaceuticals (USA) Inc · CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Status
- Ongoing
- City
- Pennington
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99563
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Address 1
- 73 Route 31 N
- Postal code
- 08534-3601
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
- Recall number
- D-0745-2026
- Reason for recall
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Recall initiation date
- 20260805
- Center classification date
- 20260807
- Report date
- 20260812
- Code info
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Product description
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
- Harmonized identifiers (openFDA)
- Application number
- ANDA209488
- Brand name
- MIRABEGRON
- Generic name
- MIRABEGRON
- Manufacturer name
- Zydus Pharmaceuticals (USA) Inc.
- Product NDC
- 70710-1159, 70710-1160
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- MIRABEGRON
- RxCUI
- 1300791, 1300801
- SPL ID
- df34c0c9-8528-4fd6-a408-e1d44da0f156
- SPL set ID
- 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2
- Package NDC
- 70710-1159-3, 70710-1159-9, 70710-1159-1, 70710-1160-3, 70710-1160-9, 70710-1160-1
- Is original packager
- true
- Nui
- N0000185008, N0000185007, N0000182137, N0000190114, N0000185503
- Pharm class epc
- beta3-Adrenergic Agonist [EPC]
- Pharm class moa
- Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- UNII
- MVR3JL3B2V