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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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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
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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
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