BETHESDA, MD 04 September 2012—The presence of crystals in liquid-filled nimodipine capsules led Caraco Pharmaceutical Laboratories Ltd.'s parent company today to announce a recall of lots 3305.039A and 3305.039B.
Sun Pharmaceutical Industries Inc., the parent company, said crystallization of the capsules' contents could affect the bioavailability of nimodipine.
Nimodipine is a calcium channel blocker that is given to patients with subarachnoid hemorrhage to improve their neurological outcome.
Sun said the crystals were reported by a customer.
The company said the two lots were distributed between January 19 and April 24.
Health care providers in possession of nimodipine capsules from either lot are being told to contact Inmar Inc., at 800-967-5952 (select option 1 then option 3) 8 a.m. to 5 p.m. EST Monday through Friday, for more information about the recall.
Sun, with headquarters in India, said the capsules were manufactured by Pharmaceutics International Inc., a Maryland company.
Two years ago, according to FDA, Sun recalled 14,824 cartons of nimodipine because the capsules, manufactured by Pharmaceutics International, leaked.