fda
21 records
FDA Drug Recall: Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Ma
2026-01-21
Class II — Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
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FDA Drug Recall: Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged
2025-02-26
Class I — Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
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FDA Drug Recall: Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manuf
2023-03-08
Class II — Sub-Potent Drug: Out of specification for assay at the 24 month interval.
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FDA Drug Recall: Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing
2021-07-14
Class II — Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
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FDA Drug Recall: Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. b
2019-08-21
Class II — Failed dissolution specifications
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FDA Drug Recall: Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx
2019-08-21
Class II — Failed dissolution specifications
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FDA Drug Recall: FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx on
2019-05-15
Class I — Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
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FDA Drug Recall: Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE
2017-07-12
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE
2017-07-12
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE
2017-07-12
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufact
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufact
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx onl
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufact
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx On
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx On
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx On
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx On
2017-04-12
Class III — Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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FDA Drug Recall: NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx
2015-05-20
Class II — Failed Dissolution Specification; 6 month time point
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FDA Drug Recall: Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only.
2014-10-01
Class II — Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
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fda_adverse
3 records
FDA AE Manufacturer: Alvogen, Inc.
Drug adverse event reporter — Product: OXYCODONE AND ACETAMINOPHEN
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lobbying
5 records
Lobbying Client: ALVOGEN
Lobbied by GREEN MOUNTAIN STRATEGIES LLC DC — Pharmaceutical company developing and manufacturing generic, brand and biosimilar products
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Lobbying Client: ALVOGEN
Lobbied by GREEN MOUNTAIN STRATEGIES LLC DC — Pharmaceutical company developing and manufacturing generic, brand and biosimilar products
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ny_corps
1 records
NY Corp: ALVOGEN, INC.
2010-03-08
FOREIGN BUSINESS CORPORATION | County: Chenango | Jurisdiction: Delaware
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USASpending
2 records
Federal Award: ALVOGEN, INC. — $227,679,090
2025-06-30
OSELTAMIVIR PHOSPHATE 75MG CAPSULES (NDC: 47781-470-13); 10 CT. BLISTERS PACKS AND OSELTAMIVIR PHOSPHATE 30MG CAPSULES (NDC: 47781-468-13); 10 CT. BLISTERS PACKS.
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Federal Contractor: ALVOGEN, INC.
Total awards: $227,679,184 | UEI: LJNNGDV77Y98 | DUNS: 008057330
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