FDA recall D-0498-2024

Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

Reason for recall

Presence of foreign substance: plastic-like substance.

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2024-05-07

Report date

2024-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0498-2024