Class I - Dangerous
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality.
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
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
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
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
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.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Class I - Dangerous
Presence of Particulate Matter.
Class I - Dangerous
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
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
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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
Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class I - Dangerous
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.