GlaxoSmithKline Recalls Antihypertensive Drug Made at Novartis Facility - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

GlaxoSmithKline Recalls Antihypertensive Drug Made at Novartis Facility

ePT--the Electronic Newsletter of Pharmaceutical Technology

GlaxoSmithKline is recalling 394,230 bottles containing its antihypertensive drug DynaCirc CR (isradipine) controlled-release tablets, according to a Feb. 22, 2012, FDA enforcement report. The lots are being recalled due to concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packing process at the Lincoln, Nebraska, facility of Novartis Consumer Health, where the product is made.

The products being recalled are:

  • DynaCirc CR (isradipine) controlled release tablets, 5 mg, 30-count bottles, Rx only; NDC 0173-0784-01; UPC 3 0173-0784-01 8. Recall # D-1212-2012;
  • DynaCirc CR (isradipine) controlled release tablets, 10 mg, 30-count bottles, Rx only; NDC 0173-0785-01; UPC 3 0173-0785-01 5. Recall # D-1213-2012

The affected lots are:

  • Lot #: 10084536, Exp 12/12; 10102915, Exp 03/13; 10102916, Exp 06/13; 10107157, Exp 07/13; and 10108172, Exp 09/13;
  • Lot #: 10087732, Exp 01/13; 10091069, 10094639, Exp 03/13; 10102913, Exp 07/13; and 10109327, Exp 10/13

In January 2012, Novartis Consumer Health issued a voluntary recall of lots with select bottle packaging configurations for several of its over-the-counter products (Excedrin, NoDoz, Bufferin, Gas-X Prevention), sold in the United States and manufactured at its Lincoln facility. Novartis initiated the recall because the products may have contained stray tablets, capsules, or caplets from other Novartis products, or contained broken or chipped tablets.

At the time of the recall in January, Novartis temporarily suspended operations and shipments from the site. Novartis said it planned to gradually resume operations at its Lincoln site following implementation of planned improvements and in agreement with FDA.

See related Pharm Tech story:

Novartis Issues Recall and Suspends Operations at US Facility


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here