FDA Issues Recall On Nimodipine Capsules
September 11, 2012
The U.S. Food and Drug Administration (FDA) works to ensure that all medications are safe. When a drug doesn’t meet safety standards, it’s pulled from the market by a recall. According to a press release from the FDA, a drug manufactured by Sun Pharmaceutical Industries, Inc., has been recalled after being found to potentially lead to drug injuries, including bleeding in the brains of patients who take the medication.
The announcement stated that a lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd., had been found to contain vials of the drug where the medication had crystalized. Experts say that the crystallization may negatively affect the potency of the drug, causing it to not work for its intended use of stopping bleeding in the brain.
The announcement states that the product comes in packs of 30 and 100 and only two lots were affected, including:
- 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))
Facilities in possession of the affected medication have been asked to stop use of it immediately and contact their distributor for further information, while patients taking the medication have been instructed to contact their healthcare provider.