FDA Recalls（５月27日）
公開日時 2009/06/04 04:00
| Chart: FDA Recalls -- May 27, 2009 |
| FDA Recalls |
27-May-09 |
| CLASS I |
| Morphine Sulfate Immediate Release Tablets 15mg |
| Used as rescue medication in kits for clinical study KF5503/16, 100-count bottles. |
| Manufacturer: |
KV Pharmaceutical Co., Westport, Saint Louis, Mo. |
| Recalled by: |
Almac Clinical Services LLC, Norristown, PA, by letter and FDA press release on Jan. 15, 2009. Firm-initiated recall is complete. |
| Distribution: |
CA, FL, IN, LA, NC, NY, OH, PA, TX, Argentina, Chile, France, Latvia and Ukraine; 1,070 bottles. |
| Reason: |
Tablet thickness; possibility of oversized tablets which could result in superpotent dose. |
| Recall number: |
D-420-2009. |
| CLASS II |
| Metoprolol Tartrate Tablets |
| USP, 100 mg, 1000 count bottles, Rx only, NDC number 0093-0734-10. |
| Manufacturer: |
Teva Pharmaceuticals Industries, Ltd., Kfar Sava, Israel. |
| Recalled by: |
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on April 1, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide; 2,108 bottles. |
| Reason: |
The affected lots may contain some tablets exceeding weight requirements. |
| Recall number: |
D-419-2009. |
| 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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