FDA Recalls(4月29日)
公開日時 2009/05/14 04:00
FDA Recalls |
29-Apr-09 |
CLASS II |
Calan, Verapamil HCl Tablets |
80 mg, 100 tablet bottles, Rx only; NDC 0025-1851-31. |
Manufacturer: |
Pfizer, Carolina, PR. |
Recalled by: |
Pfizer, New York, NY, by letter on Feb. 18, 2009. Firm-initiated recall is ongoing. |
Distribution: |
Nationwide; 9,445 bottles. |
Reason: |
Product does not meet dissolution specifications on stability. |
Recall number: |
D-237-2009. |
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. |
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