Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Gle…
Glenmark Pharmaceuticals Inc., USA · CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Status
- Ongoing
- City
- Mahwah
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 96194
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address 1
- 750 Corporate Dr
- Address 2
- N/A
- Postal code
- 07430-2009
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the U.S
- Recall number
- D-0243-2025
- Product quantity
- 58,416 bottles
- Reason for recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- Recall initiation date
- 20250129
- Center classification date
- 20250220
- Report date
- 20250226
- Code info
- Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.
- Product description
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
- Harmonized identifiers (openFDA)
- Application number
- ANDA079019
- Brand name
- ATOMOXETINE
- Generic name
- ATOMOXETINE
- Manufacturer name
- Northstar Rx LLC
- Product NDC
- 16714-755, 16714-756, 16714-757, 16714-758, 16714-759, 16714-760, 16714-761
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- ATOMOXETINE HYDROCHLORIDE
- RxCUI
- 349591, 349592, 349593, 349594, 349595, 608139, 608143
- SPL ID
- a0f55e56-0899-430c-b25d-475d713f3a93
- SPL set ID
- 133a4b65-762b-4712-baba-2442546f0379
- Package NDC
- 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01
- Is original packager
- true
- Upc
- 0316714760018, 0316714755014, 0316714756011, 0316714761015, 0316714757018
- UNII
- 57WVB6I2W0