Sun 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. The crystallization of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability. The product may no longer be bioequivalent and may potentially affect patients who are being treated for a medical emergency.
The following lot numbers to the consumer level are affected:
Lot Number: 3305.039A, NDC Number: 57664-135-65 (Unit Dose Blisters of 100 (25×4))
Lot Number: 3305.039B, NDC Number: 57664-135-64 (Unit Dose Blisters of 30 (5×6))
Patients and healthcare providers using Nimodipine Capsules, 30mg, with one of the above lot numbers should discontinue use of the product.
Nimodipine Capsules, 30mg, are used to decrease problems due to subarachnoid hemorrhage.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm318207.htm.