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