| Chart: FDA Recalls -- May 20, 2009 |
| FDA Recalls |
20-May-09 |
| CLASS II |
| Daytrana (Methylphenidate Transdermal System) |
| (a) 10 mg, 30 patches per box, Rx only, NDC 54092-552-30; (b) 15 mg 30 patches per box, Rx only, NDC 54092-553-30; (c) 20 mg 30 patches per box, Rx only, NDC 54092-554-30; (d) 30 mg 30 patches per box, Rx only, NDC 54092-555-30. |
| Manufacturer: |
Noven Pharmaceuticals, Inc., Miami, FL. |
| Recalled by: |
Shire PLC, Wayne, PA, by press release and letter on March 20, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
CA, FL, IL, LA, MI, MN, MO, ND, NY, OH, PA, SC and VT; 245,204 boxes. |
| Reason: |
Defective delivery system, mechanical (peel force out of specification). |
| Recall numbers: |
D-410/413-2009. |
| Klonopin Wafers (Clonazepam Orally Disintegrating Wafers) CIV |
| 2 mg, carton of 60 blistered wafers (10 x 6), Rx only. NDC 0004-0283-22. |
| Manufacturer: |
Cardinal Health, Swindo, UK. |
| Recalled by: |
Hoffmann La Roche, Inc., Nutley, NJ, by letters on March 26, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide; 957 units. |
| Reason: |
Subpotent. |
| Recall number: |
D-414-2009. |
| Sterile Vancomycin HCl; A-Hydrocort (Hydrocortisone Sodium Succinate) for Injection |
| (a) USP, sterile lyophilized powder, equivalent to 5 g vancomycin, pharmacy bulk package (100-ml vials) not for direct infusion, for intravenous use, NDC 0409-6509-01, Rx only; (b) USP, for intravenous use, sterile powder packaged in a fliptop vial, equivalent to 1 g vancomycin, lyophilized, 10 units per immediate carton, 5 cartons per shipping case, Rx only, NDC 0409-6533-01; (c) USP, 100 mg, sterile powder for Injection packaged in a single-dose vial, hydrocortisone activity/2 mL (when mixed), Rx only, NDC 0409-4856-05. |
| Manufacturer: |
Hospira, Inc., McPherson, KS. |
| Recalled by: |
Hospira, Inc., Lake Forest, IL, by letters dated Feb. 25, 2009 and e-mails on Feb. 27, 2009. Firm-initiated recall is ongoing. |
| Distribution: |
Nationwide; (a) 61,290 vials; (b) 237,800 vials; (c) 9,470 vials. |
| Reason: |
The sterility of the stoppers used on sterile products was potentially compromised. |
| Recall numbers: |
D-416/418-2009. |
| 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. |