Navigation Links
Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico
Date:7/14/2008

COLUMBUS, Ohio, July 14 /PRNewswire/ -- 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).

(Logo: http://www.newscom.com/cgi-bin/prnh/20070410/CLTU122LOGO )

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.

About Roxane Laboratories, Inc.

Roxane Laboratories is located in Columbus, OH in a modern 500,000 square foot manufacturing and laboratory facility. The facility spans 70 acres and currently employs over 1,000 people. Currently, Roxane Laboratories markets over 75 medications in nearly 250 package sizes, focusing on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, cytotoxics and CII narcotics.

Roxane Laboratories, Inc., is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT and a member of the Boehringer Ingelheim group of companies.

About Boehringer Ingelheim

Boehringer Ingelheim Corporation based in Ridgefield, CT, is the US headquarters to seven subsidiaries and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and approximately 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of US $15.0 billion (10.9 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information on Boehringer Ingelheim, please visit http://us.boehringer-ingelheim.com.


'/>"/>
SOURCE Roxane Laboratories, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Roxane Laboratories, Inc. Announces the Launch of Oxcarbazepine Tablets, 150mg, 300mg and 600mg
2. Roxane Laboratories, Inc. Announces the Launch of Balsalazide Disodium Capsules, 750mg
3. Roxane Laboratories, Inc. Announces the Launch of Granisetron Hydrochloride Tablets, 1mg
4. Roxane Laboratories, Inc. Announces the Launch of Acarbose Tablets
5. Roxane Laboratories, Inc. Announces the Launch of Ramipril Capsules
6. Roxane Laboratories, Inc. Announces the Approval of Morphine Sulfate Tablets and Oral Solution
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
9. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
10. Forest Laboratories, Inc. Sets Date and Conference Call for Fiscal 2008 Second Quarter Earnings
11. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/13/2017)... ... January 13, 2017 , ... ... world’s first and most comprehensive franchise ranking. Recognized by entrepreneurs and franchisors as ... for its exceptional performance in areas including financial strength and stability, growth rate, ...
(Date:1/13/2017)... ... January 13, 2017 , ... "Devotions from the Heart" ... crafts, and antique hunting. She and her husband, Gene, reside in Missoula, Montana, with ... wait and learn to lean upon His strength., So keep trusting in the Master ...
(Date:1/13/2017)... Viejo, California (PRWEB) , ... January 13, 2017 , ... ... back into any video project," said Christina Austin - CEO of Pixel Film Studios. ... drop transition presets. Each preset contains a unique shadow fade that masks the first ...
(Date:1/13/2017)... ... January 13, 2017 , ... Dr. Les Latner, ... of a fundraising campaign for the American Academy of Cosmetic Dentistry Charitable Foundation ... assist in rebuilding the smiles and lives of adults who have suffered dental ...
(Date:1/13/2017)... ... January 13, 2017 , ... Sharon Kleyne, America’s leading water researcher, advocate ... Water, Global Climate Change and Your Health on Voice America, celebrated on January 9th ... yesterday,” said Sharon Kleyne to her listening audience, “yet here it is the beginning ...
Breaking Medicine News(10 mins):
(Date:1/13/2017)... 12, 2017   JDRF , the leading ... is pleased to announce that after more than ... Medicare & Medicaid Services (CMS) has recognized continuous ... for use in making diabetes treatment decisions as ... them eligible for coverage under Medicare. JDRF has ...
(Date:1/13/2017)... , Jan. 13, 2017 Over the last 10 years ... developing rapidly (6% – 10% yoy) and are expected to deliver remarkable ... the region, followed by Thailand , the ... , and Singapore .  A member of the G20 ... represents almost 40% of the SEA,s economic output and the largest pharma ...
(Date:1/12/2017)... Ind. , Jan. 12, 2017 Zimmer ... leader in musculoskeletal healthcare, announced today that it has ... and the U.S. Securities and Exchange Commission (SEC) to ... (FCPA) matters involving Biomet, Inc., as well as in ... to final judgment that Biomet entered into with DOJ ...
Breaking Medicine Technology: