Recall: D-0632-2022

Class II - Potentially Harmful

Class IIClassification

2022-02-15Initiated

TerminatedStatus

Macleods Pharma Usa IncFirm

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

cGMP deviations

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.