Recall
Get alerts

atomoxetine

15 recalls on record

Get alerts
S
Safecor Health, LLC — Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Lt

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals L

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Lt

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Lt

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Lt

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Lt

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

G
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Lt

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.