Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
Reported: February 26, 2025 Initiated: January 29, 2025 #D-0233-2025
Product Description
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
Reason for Recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 175,920 bottles
- Distribution
- Nationwide within the U.S
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 175,920 bottles.
Why was this product recalled? ▼
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 26, 2025. Severity: Moderate. Recall number: D-0233-2025.
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