ATOMOXETINE HYDROCHLORIDE Recall D-0239-2025
Description: Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
ATOMOXETINE HYDROCHLORIDE Recall D-0239-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0239-2025 |
| Event ID | 96194 |
| Brand | ATOMOXETINE |
| Generic Name | ATOMOXETINE |
| Manufacturer | ATOMOXETINE |
| Original Package? | 1 |
| Active Substance | ATOMOXETINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide within the U.S |
| Quantity | 119,040 bottles |
| Recall Reason | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250226 |
| Product NDC | 16714-755 16714-756 16714-757 |
| Drug UPC | 0316714761015 0316714758015 0316714759012 |
| Recall Initiation Date | 20250129 |
| Report Date | 20250226 |
| Classification Date | 20250220 |
| Address | 750 Corporate DrN/A Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 57WVB6I2W0 |
| Drug Application Number | ANDA079019 |
| Structured Product Labeling (SPL ID) | fc2fb27b-9a53-4df1-874e-bb2ed5157aef |
| Structured Product Labeling (SPL Set ID) | 133a4b65-762b-4712-baba-2442546f0379 |
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