FDA recall D-0974-2022

Strides Pharma Inc. · Class II · drug

Product

Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08

Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2022-05-18
Report date: 2022-06-08
Termination date: 2023-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0974-2022