FDA-Drug2014-12-03Class III

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

Zydus Pharmaceuticals USA Inc
Hazard

Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.

Sold states
Nationwide
Affected count
15,144 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2015

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