Safety Alerts & Recalls

What does this mean?

This recall for Amlodipine Besylate and Benazepril HCl Capsules, 5mg/10mg was issued at a warehouse/retail level only, with the FDA and the manufacturer determining that any recalled product already dispensed to patients does not pose a significant health risk. However, if you take the combination capsule with Amlodipine Besylate and Benazepril HCl Capsules, 5mg/10mg and are concerned, you should consult with your physician, especially if you think your medicine is not working as well or if you are experiencing side effects from your medicine.

Novartis Issues Recall Of Single Lot of Amlodipine/Benazepril Capsules at Warehouse/Retail Level

Novartis Pharmaceuticals Corp. is recalling a single lot of Amlodipine Besylate and Benazepril HCl Capsules, 5mg/10mg (equivalent to amlodipine 5 mg and benazepril 10 mg) made by Sandoz. Lot number F1031 is being recalled because routine testing of samples from this lot found one capsule that did not contain the Benazepril 10 mg tablet.

Amlodipine Besylate and Benazepril HCl capsules are a combination capsule that is commonly used to control high blood pressure. It is also sold under the brand name Lotrel. This recall alert only applies to this single lot of Amlodipine Besylate and Benazepril HCl Capsules, 5mg/10mg from Novartis/Sandoz. No other amlodipine Besylate and Benazepril HCl 5mg/10mg capsules or Lotrel products are involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-03-16
Last Updated: 2010-03-22
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