fda
24 records
FDA Drug Recall: Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only,
2025-01-22
Class II — Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
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FDA Drug Recall: Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only,
2025-01-22
Class II — Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0
2024-12-18
Class II — Superpotent Drug and Subpotent Drug: potency failures obtained
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FDA Drug Recall: Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only M
2024-07-24
Class II — Failed Impurities/Degradation Specifications
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FDA Drug Recall: Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only,
2024-07-24
Class II — Failed Impurities/Degradation Specifications
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FDA Drug Recall: Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: M
2024-05-08
Class III — Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
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FDA Drug Recall: Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water fo
2023-06-14
Class II — CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or...
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FDA Drug Recall: Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceu
2022-11-23
Class II — Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
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FDA Drug Recall: Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syrin
2022-11-16
Class I — Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
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FDA Drug Recall: Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2
2022-10-05
Class II — Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
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FDA Drug Recall: Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only,
2022-05-18
Class II — Failed Dissolution Specifications: low out of specification results for dissolution.
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FDA Drug Recall: alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distribu
2022-05-11
Class II — Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
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FDA Drug Recall: Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx on
2021-10-06
Class II — Failed Dissolution Specifications
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FDA Drug Recall: Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: My
2021-09-22
Class III — Failed Impurities/Degradation Specifications; out of specification for Related Compound
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lobbying
3 records
ny_corps
1 records
NY Corp: VIATRIS INC.
2016-03-18
DOMESTIC BUSINESS CORPORATION | County: Richmond | Jurisdiction: New York
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SEC EDGAR
1 records
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