FDA Recalls（７月１日）
公開日時 2009/07/07 04:00
| FDA Recalls |
1-Jul-09 |
| CLASS II |
| Adagen (pegademase bovine) injection |
| Four 1.5 mL single-dose vials, 250 units per mL, sterile, refrigerate, Rx only; NDC 57665-001-01. |
| Manufacturer: |
Enzon Pharmaceuticals, Inc., Indianapolis, IN. |
| Recalled by: |
Manufacturer, by letter dated March 27, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
TN, Australia, Colombia and France; 308 4-vial packs. |
| Reason: |
Exceeded impurity specification; 6-month stability testing. |
| Recall number: |
D-1227-2009. |
| CLASS III |
| Oxycodone HCl Oral Solution |
| USP, 5 mg/mL, C-II packaged in 5 mL unit dose cups (50 unit Dose Cups/case) and 500 mL bottles (12 bottles/case), Rx only, unit dose NDC 66689-024-50, bottle NDC 66689-024-16. |
| Manufacturer: |
VistaPharm, Inc., Largo, FL. |
| Recalled by: |
Manufacturer, by letter on April 6, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide; 47,750 unit dose cups, and 24 bottles. |
| Reason: |
The product is mis-labeled in that the expiration date issued exceeds the current expiration date duration that is assigned. |
| Recall number: |
D-1222-2009. |
| Xopenex (levalbuterol HC1) Inhalation Solution |
| 1.25 mg/3 mL; sterile unit-dose vials. |
| Manufacturer: |
Catalent Pharma Solutions, LLC, Woodstock, IL. |
| Recalled by: |
Sepracor, Inc., Marlborough, MA, by e-mail on May 7, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
OH, TN; 20,000 units. |
| Reason: |
Incorrect expiration date. |
| Recall number: |
D-1223-2009. |
| 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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