Safety Alerts & Recalls

What does this mean?

Please check your prescription to see if it is Nimodipine 30 mg capsules labeled with one of the recalled lot numbers. If you think you have the recalled lot number, you should not take these capsules and be sure to take capsules from a different lot. You should also call the following number for more information about the recall: Inmar Inc. at 1-800-967-5952 (Option 1 then Option 3). Representatives are available Monday through Friday, 8 AM to 5 PM EST.

If you are not sure if you have recalled capsules or if you need replacement capsules, please follow up with your healthcare provider or pharmacist right away for assistance.

As always, please contact your healthcare provider for additional instructions or guidance if you have any medical questions or concerns.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Sun Pharmaceutical Recalls Select Lots of Nimodipine Capsules

Sun Pharmaceutical Industries, Inc. (Sun Inc.) announced that it is voluntarily recalling select lots of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Nimodipine capsules are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain).

Sun Inc. issued the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot. The presence of the crystals could adversely affect the drug levels in a patient who had taken the recalled product which in turn may potentially change the product’s effectiveness or risk of side effects.

No adverse events have been reported at this time. However, as a precautionary measure, Sun Inc. is recalling the following lot numbers to minimize any potential risk to patients: 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))

For more information, please visit: more information here

Source: FDA
Publication Date: 2012-09-05
Last Updated: 2012-09-05

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