FDA recall D-0895-2023

Product

Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08

Reason for recall

Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2023-06-26

Report date

2023-07-12

Termination date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0895-2023