FDA-Drug2017-09-20Class III
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
Ascend Laboratories LLC
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.
Sold states
Nationwide in the USA.
Affected count
1212 bottles
Manufactured in
180 Summit Ave Ste 200, N/A, Montvale, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1134-2017Don't want to check this manually?
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