Roxane Laboratories Recalls Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico.

Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico

Contact:
Jason Kurtz
440-201-3668

FOR IMMEDIATE RELEASE -- Columbus, Ohio -- July 14, 2008 -- Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Sodium Polystyrene Sulfonate Suspension is used to treat hyperkalemia (an elevated blood level of the electrolyte potassium).

Roxane Laboratories' number one priority is for the safety of patients who use our products. A sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Roxane Laboratories believes that this may be attributed to yeast contamination in one lot of high-density polyethylene bottles received from a supplier. There are various manifestations of yeast infections. The risk of developing a yeast infection depends on how immunocompromised the patient is. Additionally, there are a range of symptoms in a yeast infection from thrush, skin rash, and blood infections (sepsis). If patients develop an infection they should consult their physician. Due to the potential risks that could occur in immunocompromised patients, Roxane Laboratories is voluntarily recalling lot 856396A. Although there have been no testing failures associated with lot 856693A, this additional lot is also being included in the recall as a precautionary measure because the same lot of bottles was used in both finished product lots. All other product parameters were within specification and product efficacy is not impacted. There have been no complaints or adverse events reported for the affected lots. This recall is limited to the two lot numbers listed. No other Roxane Laboratories, Inc. products or lots are impacted by this recall.

Information has been sent to Pharmacists alerting them of the details pertaining to this recall. As described in these recall communications, pharmacists who may have dispensed Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lots 856396A and 856693A are instructed to contact those patients to return the affected product to the pharmacist.

Pharmacists and wholesalers that have any Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A or Lot 856693A have been instructed to discontinue distribution and use of these lots immediately and contact Capital Returns at 888.839.7837 for any questions regarding the recall returns. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800.962.8364.

Advice For Patients Taking Sodium Polystyrene Sulfonate Suspension USP, 15 g/60 Ml Unit Dose Bottles

If your pharmacist has notified you that you may have received a bottle from one of the lots listed in this recall, please return your Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles to your pharmacist.

If you have NOT been notified by your pharmacist, please check your product to determine if it is from either of the two affected lots: Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A Exp April 2010, or Lot 856693A Exp May 2010. If the product has either of these two lot numbers on the bottle, please contact your pharmacist for further instructions. This recall has been limited to these two specific lots.

Roxane Laboratories is working with the US FDA on this voluntary recall. The products discussed in this press release are available by prescription only, and no injuries have been reported in relation to this issue.

Tags: Roxane Laboratories, FDA Recall, Medical Recalls, Medicine Recall, hyperkalemia, yeast contamination, immunocompromised, yeast infection

Sage Products Inc Recalls 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation.

Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Contact:
Kym Affinito or Mike Nygren
815-455-4700

FOR IMMEDIATE RELEASE -- CARY, IL -- June 27, 2008 -- As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2% CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF. The intended application of the 2% CHG Cloth product is topical, for the skin only, and it is not for oral or internal use.
The recall includes the following products:

Product Code Number	Lot Number	Product Code Number	Lot Number
9705	10722	9707	10672
9705	10729	9707	10753
9706	10718	9707	10755
9707	10357	9707	10944
9707	10365
9707	10641

Product was distributed to U.S. hospitals and medical centers nationwide. Affected product was shipped between 4/28/08 and 6/19/08. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration. Sage Products has received no reports of patient injury. No other products from Sage are included in this recall.

Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Additional information is posted at www.sageproducts.com/recall.

Sage Products Customer Service hotline: 1-800-421-6556.

Return unused product to:
Sage Products Inc.
C/O Customer Service Department
3909 Three Oaks Road, Cary, IL 60013

Tags: Medical Recalls, Chlorhexidine Gluconate Cloth Recall, Sage Products Inc Recall

Genzyme Corporation Recalls Thymoglobulin

Thymoglobulin

DATE RECALL INITIATED:

April 9, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Anti-thymocyte Globulin (Rabbit) 25 mg/vial
NDC # 58468-0080-1
Lot Numbers: C7014C01 (Expires May 31, 2010)
C7008C01 (Expires March 31, 2010)
TH175-05 (Expires October 4, 2009)

MANUFACTURER:

Genzyme Corporation
Framingham, Massachusetts

REASON:

Genzyme Corporation , Genzyme Europe B.V., and Genzyme Polyclonals, S.A.S. are initiating a voluntary recall of Thymoglobulin finished product lots: C7014C01, C7008C01, and TH175-05. This recall was initiated when Thymoglobulin lot C7014C01 failed a periodic stability test based upon appearance of the reconstituted product. Reconstituted solution from lot C7014C01 initially passed this stability test prior to market release. The specification for the appearance of reconstituted Thymoglobulin solution is a clear, limpid to slightly opalescent liquid. Samples from lot C7014C01 have recently exceeded the slightly opalescent stability specification based upon visual examination of the reconstituted product. The 2 additional lots involved in this recall, lot numbers TH175-05 and C7008C01, are being recalled based on a predicted stability failure for appearance prior to the labeled expiration dates. Customers are asked to immediately discontinue all use of these lots and to return all Thymoglobulin vials to Genzyme Corporation.

tag: FDA Recall, Medical Recalls, Thymoglobulin Recall, Genzyme Corporation Recall, Anti-thymocyte Globulin,

Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps Recall

Class I Recall: Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps

Date Recall Initiated	January 21, 2008
Product:	Medtronic Neuromodulation Implantable Infusion Pumps: SynchroMed EL Implantable Infusion Pump, Models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, 8627L-18 SynchroMed II Implantable Infusion Pump, Models 8637-20, 8637-40, IsoMed Implantable Infusion Pump, Models 8472-20, 8472-35, 8472-60. The implantable components of the infusion systems listed above include the pump, a side catheter access port, catheters, and/or catheter accessories.
Use:	These devices administer drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories.
Recalling Firm:	Medtronic Neuromodulation 800 53rd Avenue NE Minneapolis, Minnesota 55440-1250
Reason for Recall:	The company updated the labeling for the devices to include current patient management and treatment recommendations. The company also received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. For more detailed information, please see the link below to the company’s press release.
Public Contact:	Patients or customers may contact Medtronic Neuromodulation at 1-800-707-0933 from Monday - Friday, 7:00 a.m. – 6:00 p.m. (Central Standard Time) or by emailing the company at: http://www.medtronic.com/corporate/contact.jsp
FDA District:	Minneapolis
FDA Comments:	On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card. For more information about this recall, including Medtronic's letter to physicians, please see the company’s press release at: http://wwwp.medtronic.com/Newsroom/ NewsReleaseDetails.do?itemId=1205958103681 Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Online:www.fda.gov/MedWatch/report.htm Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 FAX: 1-800-FDA-0178

tag: Medical Recalls, FDA Recall, Medtronic Neuromodulation SynchroMed EL, SynchroMed II, IsoMed Implantable Infusion Pumps Recall