ATOMOXETINE
Wed Feb 26 2025
1 of 20
Summary
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. | Glenmark Pharmaceuticals Inc., USA | Nationwide within the U.S | 87,600 bottles |
| Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. | Glenmark Pharmaceuticals Inc., USA | Nationwide within the U.S | 80,160 bottles |
| 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. | Northstar Rx LLC | Nationwide within the U.S | 119,040 bottles |
| Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01. | Northstar Rx LLC | Nationwide within the U.S | 58,368 bottles |
| Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30. | Glenmark Pharmaceuticals Inc., USA | Nationwide within the U.S | 70,032 bottles |
| Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. | Northstar Rx LLC | Nationwide within the U.S | 133,824 bottles |
| Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30. | Glenmark Pharmaceuticals Inc., USA | Nationwide within the U.S | 56,208 bottles |
| 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. | Northstar Rx LLC | Nationwide within the U.S | 58,416 bottles |
| Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30. | Glenmark Pharmaceuticals Inc., USA | Nationwide within the U.S | 175,920 bottles |
| Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. | Glenmark Pharmaceuticals Inc., USA | Nationwide within the U.S | 39,168 bottles |
| Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. | Northstar Rx LLC | Nationwide within the U.S | 53,952 bottles |
| Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30. | Glenmark Pharmaceuticals Inc., USA | Nationwide within the U.S | 190,320 bottles |
| Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01. | Northstar Rx LLC | Nationwide within the U.S | 120,000 bottles |
| Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01. | Northstar Rx LLC | Nationwide within the U.S | 233,040 bottles |