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> Media Gallery > Latest News > May 02, 2009
 
RANBAXY VOLUNTARILY RECALLS NITROFURANTOIN CAPSULES IN THE U.S.
Gurgaon, India, May 02, 2009

Ranbaxy Pharmaceuticals Inc. (RPI) announced today that it is conducting a voluntary recall of all lots of Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, USP 100 mg, currently on the market in the U.S.

Although certain lots of the product were determined to not be in conformity with the approved laboratory specifications, Ranbaxy decided to recall all the lots, as a matter of abundant caution, given its commitment to the health and safety of patients. Ranbaxy is continuing to look into the cause of such non-conformity.

The recall is being conducted in coordination with the FDA and will be a retail level recall. To the best of Ranbaxy’s knowledge, the recalled product is unlikely to produce any serious adverse health effects. However, there is a remote possibility that the non-conforming product may increase the incidence of local non-serious gastrointestinal adverse events such as nausea and vomiting. All patients presently consuming and/or prescribed this formulation should consult their physicians for alternate and appropriate medication/treatment options.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

Company Contacts for Media:

India Contacts:

Ramesh L. Adige
President - Corporate Affairs and Global Corporate Communications
Ranbaxy Laboratories Ltd.
Plot 90, Sector 32, Gurgaon
Haryana122001, India
Tel: +91-124-4135000
e-mail: ramesh.adige@ranbaxy.com

or

Raghu Kochar
Director-Corporate Communications
Ranbaxy Laboratories Ltd.
Plot 90, Sector 32, Gurgaon
Haryana122001, India
Tel: +91-124-4135141 / Mob: 9811617256
e-mail: raghu.kochar@ranbaxy.com

or

Krishnan Ramalingam
General Manager- Corporate Communications
Plot 90, Sector 32, Gurgaon
Haryana122001, India
Tel: +91-124-4135143 / Mob: 9810042540
e-mail: krishnan.ramalingam@ranbaxy.com

USA Contact:

Charles M. Caprariello
Vice President, Corporate Communications .
Ranbaxy Inc.
(609) 720-5615
email : chuck.caprariello@ranbaxy.com