FDAFDA · Food and drugs·Recall number D-1134-2017
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
Published September 20, 2017 · Recall initiated: May 5, 2017
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
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- Ascend Laboratories LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: 6142626, Exp 09/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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