FDA-Drug2022-03-09Class II

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

Macleods Pharma Usa Inc
Hazard

cGMP deviations

Sold states
USA Nationwide
Affected count
3,672 bottles
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, NJ, United States
Products
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0632-2022

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