Nimodipine (Nimotop ®)
September 5, 2012
A recall of nimodipine capsules was announced due to the presence of crystals within the capsule solution. The manufacturer, Sun Pharmaceutical Industries, Inc. (Sun Inc), is voluntarily recalling the lot after being identified by a customer complaint.
The recall was initiated September 5, 2012, for one lot of nimodipine 30-mg capsules. The following are the lot and NDC numbers associated with potentially affected products:
- Lot Number: 3305.039A, NDC Number: 57664-135-65 (unit dose blisters of 100)
- Lot Number: 3305.039B, NDC Number: 57664-135-64 (unit dose blisters of 30)7
Nimodipine is marketed by Caraco Pharmaceutical Laboratories, Ltd. The affected products were distributed between January 19, 2012, to April 24, 2012.
Nimodipine is a softgel capsule filled with liquid active ingredient. It is labeled for use in subarachnoid hemorrhage to improve neurological outcomes by reducing the incidence and severity of ischemic events.1 The presence of crystals in the capsule fill solution could affect the bioavailability of the medication and potentially impact patients who are being treated for a medical emergency. To date, no adverse events have been related to this recall.
Discontinue use of the affected product. Contact your healthcare provider for any additional guidance. More information about the recall is available by contacting Inmar Inc. at 1-800-967-5952 (Option 1, then Option 3). Report any adverse events to FDA’s MedWatch Adverse Event Reporting Program.
Additional information is available at the following links:
- MedWatch Safety Alert:
- Press Release:
1. Caraco. Nimotop (nimodipine) [product information]. Detroit, MI: Caraco Pharmaceutical Laboratories, Ltd; 2012.
September 5, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.