FDA-Drug2021-06-02Class II

Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
33 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2021

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