Nimodipine Recalled for Crystallization of Fill Material
September 5, 2012
Sun Pharmaceutical Industries, Inc. recalled one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd., as a precaution. A customer complained of the presence of crystals of nimodipine within the capsule solution. The crystallization of the nimodipine fill material in the capsule could adversely affect the amount of drug that is actually absorbed from a given dose. This affect on the drug could result in problems for patients being treated for a medical emergency.
The following lot numbers are included in this recall:
- 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))
Nimodipine Capsules, 30 mg, are used to decrease problems due to bleeding in the brain.
Patients using Nimodipine Capsules, 30 mg, with one of the above lot numbers should discontinue use of the product.
For more information, please read the complete MedWatch safety alert.