Navigation Links
Sun Pharmaceutical Industries, Inc. Issues Nationwide Voluntary Recall of One Lot of Nimodipine Capsules due to Crystallization of the Fill Material

CRANBURY, N.J., Sept. 4, 2012 /PRNewswire/ -- Sun Pharmaceutical Industries, Inc. (Sun Inc) announced today that it is voluntarily recalling from users one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Sun Inc. commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot as identified by a customer complaint.  No adverse events have been reported at this time.

Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain). Nimodipine capsules 30 mg are clear yellow solution filled in oblong opaque light yellow softgel capsules, imprinted "135" in black ink. The product is supplied in unit dose blisters of 30 and 100, as described below. The affected product was distributed nationwide between January 19, 2012 and April 24, 2012.

The crystallization of the nimodipine fill material in the capsule could adversely affect the product's bioavailability. Although clinical health implications are unknown, use of the product when the nimodipine has crystallized in the capsule may be of great clinical significance. The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency.

As a precautionary measure, Sun Inc is recalling the following lot numbers to the consumer level to minimize any potential risk to patients

Lot Number: 3305.039A, NDC Number: 57664-135-65 (Unit Dose Blisters of 100 (25x4))
Lot Number: 3305.039B, NDC Number: 57664-135-64 (Unit Dose Blisters of 30 (5x6))

The recalled capsules were manufactured for Sun Inc by Pharmaceutics International, Inc. This recall is being conducted with the knowledge of the Food and Drug Administration.

Patients and healthcare providers using Nimodipine Capsules, 30 mg, with one of the above lot numbers should discontinue use of the product and should contact the following number for more information about the recall:  Inmar Inc. at 1-800-967-5952 (Option 1 then Option 3). Representatives are available Monday through Friday, 8 AM to 5 PM EST.

Patients using Nimodipine Capsules, 30 mg, who have medical questions, should contact their healthcare provider for additional instructions or guidance.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

SOURCE Sun Pharmaceutical Industries, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Avanir Pharmaceuticals Announces Enrollment Of First Patient In Study Of AVP-923 For The Treatment Of Agitation In Patients With Alzheimers Disease
2. Brand new Solid Form Co-Crystals and Amorphous Focus Morning at the Pharmaceutical Co-Crystals and Amorphous Material 2012 Summits
3. Valeant Pharmaceuticals International, Inc. Agrees To Acquire Medicis Pharmaceutical Corporation For $44.00 Per Share In Cash
4. Elevation Pharmaceuticals Presents Positive Phase 2b Results for EP-101 in COPD Patients at the European Respiratory Society Annual Congress
5. Health Outcome Liaisons Improve Decision Making for Pharmaceutical Industry Challenged by Reform and Compliance Issues
6. Lexicon Pharmaceuticals To Present At The Stifel Nicolaus 2012 Healthcare Conference
7. Sihuan Pharmaceutical Announces 2012 Interim Results
8. Novation Supports New Development in the U.S. Biosimilar Pharmaceuticals Market
9. Arena Pharmaceuticals to Present at Upcoming Investor Conferences
10. Isis Pharmaceuticals Demonstrates The Potential Of Single-Stranded RNA-Like Antisense Technology To Activate The RNAi Pathway
11. Optimer Pharmaceuticals to Present at September 2012 Investor Conferences
Post Your Comments:
(Date:6/23/2016)... BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a ... second affiliate in Latin America . ... ... ... ...
(Date:6/23/2016)... PRINCETON, N.J. , June 23, 2016  Guerbet ... of Premier Inc.,s Supplier Horizon Award . ... this year, Guerbet was recognized for its support of ... value creation through clinical excellence, and commitment to lower ... delighted to receive this recognition of our outstanding customer ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Surgical Procedure Volumes: Global Analysis (United States, ... Australia, Canada)" report to their offering. ... an essential tool for healthcare business planners, provides surgical ... looks at surgery trends with an in-depth analysis of ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... ambulance transport experience for the millions of people who require these medical transport ... taxi industry through the use of technology. Now, SmartEMS has put forth an ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, ... Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility ... home to some of the world’s leading providers of cereal and other breakfast foods. ...
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
Breaking Medicine News(10 mins):