FDA recall D-0632-2022

Product

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.

Reason for recall

cGMP deviations

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-02-15

Report date

2022-03-09

Termination date

2023-02-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

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