FDAFDA · Food and drugs·Recall number D-0257-2015
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Published December 3, 2014 · Recall initiated: October 1, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- Nationwide
- Lot
- Lot #: MP4344, Exp 04/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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