Valproate Products: Drug Safety Communication

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FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development

Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Data Summary References     Safety Announcement [6-30-2011] Normal 0 false false false MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:”Table Normal”; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:””; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:”Times New Roman”; mso-ansi-language: mso-fareast-language: mso-bidi-language:} The U.S. Food and Drug Administration [...]

Tylenol Extra Strength Caplets, 225 count bottles: Recall

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Drug Firm Annual Registration Status Download File

PK Article source: http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM197817.zip

Breakdown of FDAAA Completed Pediatric Studies

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List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)

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Exceptions and Alternative Procedures Approved Under 21 CFR 640.120

<!– –> <!– Page Last Updated: 06/28/2011 –> Page Last Updated: 06/28/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/ExceptionsandAlternativeProcedures/ucm2005885.htm

Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall

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Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall

[Posted 06/27/2011] AUDIENCE: Pharmacy, Patients ISSUE: Endo Pharmaceuticals  and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg  because some bottles may contain different strength tablets, resulting in  patients taking more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content may [...]

Nature Relief Instant Wart and Mole Remover: Recall

<!– –> <!– Page Last Updated: 06/27/2011 –> Page Last Updated: 06/27/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm260982.htm