Class III
Terminated
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
- Company
- Ascend Laboratories Llc
- Recall Initiated
- May 5, 2017
- Posted
- September 20, 2017
- Recall Number
- D-1134-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1212 bottles
- Firm Location
- Montvale, NJ, United States
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
Nationwide in the USA.
Lot / Code Info
Lot #: 6142626, Exp 09/19
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