D-1134-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- May 5, 2017
- Termination Date
- April 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1212 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 6142626, Exp 09/19