Nimodipine Capsules Face Recall
Sun Pharmaceutical Industries Inc. issued a voluntary recall of two lots of Nimodipine Capsules, 30 mg, as a precautionary measure as the nimodipine had crystallized within the capsules.
The U.S. Food and Drug Administration says the capsules, manufactured by Caraco Pharmaceutical Laboratories Ltd., are being recalled based on a consumer complaint and there have been no injuries reported.
The drug is used to reduce problems due to subarachnoid hemorrhage (bleeding in the brain), but the crystallization of nimodipine could influence the product’s bioavailability and may potentially have an adverse affect in patients who are being treated for a medical emergency.
The recalled capsules are a clear yellow solution filled in oblong and opaque light yellow soft gel capsules, imprinted with “135” in black, and were distributed between January and April 2012.
Users of capsules of the recalled lots should contact their healthcare providers for guidance and report any adverse reactions to FDA’s MedWatch Adverse Event Reporting program.
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