FDA Recalls（９月30日）
公開日時 2009/10/09 04:00
| CLASS I |
| Propofol Injectable Emulsion 1% |
| 1) 1000 mg/100 mL (10 mg/mL) in 100 mL vials, Rx only, NDC 0703-2859-01; 2) 200 mg/20 mL (10 mg/mL) in 20 mL vials, Rx only, NDC 0703-2856-01; 3) 500 mg/50 mL (10 mg/mL) in 50 ml vials, Rx only, NDC 0703-2858-01; 4) 1000 mg/100 mL (10 mg/mL) in 100 mL vials, Rx only, NDC 0703-2859-01. |
| Manufacturer: |
Teva Parenteral Medicines, Inc., Irvine, CA. |
| Recalled by: |
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by telephone, letter and press release on July 16, 2009 and by letter on July 29, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide; 268,765 vials. |
| Reason: |
Non-Sterility: contamination with endotoxins. |
| Recall numbers: |
D-1966/1969-2009. |
（The Pink Sheet 10月５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