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FDA Recalls(6月3日)

公開日時 2009/06/18 04:00
FDA Recalls 3-Jun-09
CLASS II
Furosemide Tablets
USP, 40 mg, 1000 tablets, Rx only, 0781-1966-10.
Manufacturer: Sandoz, Inc., Broomfield, CO.
Recalled by: Sandoz, Inc., Princeton, NJ, by letter on April 10, 2009. Firm-initiated recall is complete.
Distribution: Nationwide; 5773/1000-tablet bottles.
Reason: Furosemide tablets were out of specification for tablet thickness and potency.
Recall number: D-423-2009.
EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Pink Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation

(The Pink Sheet  6月15日号より)   FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから

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