CFAI
C.F.A.I.
Government Data Intelligence Services

Mayne Pharma Inc

Company NC
Found in 3 federal databases · 13 total records
fda 6 records
FDA Drug Recall: Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per C 2022-06-29
Class II — Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
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FDA Drug Recall: Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, D 2022-01-26
Class II — CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
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FDA Drug Recall: Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne P 2020-03-18
Class II — Product Mix-Up: A foreign tablet was found in bottle.
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FDA Drug Recall: Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Onl 2018-09-05
Class III — Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG105...
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FDA Drug Recall: Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Ph 2018-04-11
Class III — Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
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FDA Drug Recall: Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distribute 2017-12-06
Class II — Failed Dissolution Specifications.
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fda_adverse 4 records
FDA AE Manufacturer: Mayne Pharma LLC
Drug adverse event reporter — Product: ESTRADIOL
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FDA AE Manufacturer: Mayne Pharma
Drug adverse event reporter — Product: ESTRADIOL
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FDA AE Manufacturer: Mayne Pharma Inc.
Drug adverse event reporter — Product: DOXYCYCLINE
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FDA AE Manufacturer: Mayne Pharma Inc
Drug adverse event reporter — Product: AMETHIA
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ftc_enforcement 2 records
Hospira, Inc., and Mayne Pharma Limited, In the Matter of 2007-03-23
FTC live enforcement action FY2007; matched respondent 'Mayne Pharma Limited, In the Matter of'
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Hospira, Inc. / Mayne Pharma Limited 2007-01-18
FTC merger enforcement action FY2007 matter 710002; matched respondent 'Mayne Pharma Limited'
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lobbying 1 records
Lobbying Client: MAYNE PHARMA
Lobbied by G2G CONSULTING — Increasing access to pharmaceuticals
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