Nimodipine capsules have been recalled for crystallization issues, the U.S. Food & Drug Administration (FDA) just announced. Sun Pharmaceutical Industries, Inc. is recalling one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd.
Sun Inc. initiated the recall due to the presence of crystals of Nimodipine within the capsule solution of this lot, following a customer complaint. To date, no adverse events have been reported to the firm or agency.
As we’ve previously written, Nimodipine is a medication intended to be given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage (ruptured blood vessels in the brain) and is only available as a capsule.
The recalled Nimodipine capsules were manufactured for Sun Inc. by Pharmaceutics International, Inc. and are oblong, opaque, light yellow softgel capsules that contain a clear yellow solution. The capsules are imprinted with the numbers “135” in black ink. The product is packaged in unit dose blisters of 30 and 100 mg; was distributed, nationwide, between January 19, 2012 and April 24, 2012. As a precaution, the following two lots are being recalled:
- 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)
Nimodipine fill material crystallization in the capsule could adversely affect the product’s bioavailability. Although clinical health implications are unknown, use of the drug when the Nimodipine has crystallized in the capsule may be of great clinical significance–the product may no longer be bioequivalent and may potentially affect patients being treated for a medical emergency.
Patients and healthcare providers in possession of the recalled Nimodipine Capsules, 30 mg, should discontinue use of the drug and contact Inmar Inc., toll-free, at 1.800.967.5952 (Option 1, Option 3), Monday through Friday, from 8:00 a.m. to 5:00 p.m., Eastern Standard Time (EST).
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 by either completing and submitting the report online at www.fda.gov/MedWatch/report.htm or submitting the form by regular mail or fax (use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to address on the pre-addressed form or fax to 1.800.FDA.0178).