Nimodipine: Recall - Crystallization of Fill Material

[Posted 09/05/2012]

AUDIENCE: Emergency Medicine, Pharmacy, Patient

ISSUE: Sun Pharmaceutical Industries, Inc. recalled one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. 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.

BACKGROUND: Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain). The following lot numbers to the consumer level are affected:
Lot Number: 3305.039A, NDC Number: 57664-135-65 (Unit Dose Blisters of 100 (25x4))
Lot Number: 3305.039B, NDC Number: 57664-135-64 (Unit Dose Blisters of 30 (5x6))

RECOMMENDATION: Patients and healthcare providers using Nimodipine Capsules, 30 mg, with one of the above lot numbers should discontinue use of the product. Patients who have medical questions should contact their healthcare provider for additional instructions or guidance.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/04/2012 – Press Release - Sun Pharmaceutical Industries]