FDA recall D-1545-2020

Hetero Labs Limited (Unit V) · Class II · drug

Product

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

Reason for recall

Failed Tablet/Capsule Specification; complaint of bulging tablet

Distribution

Product was distributed to major wholesalers/distributors throughout the United States.

Key facts

Status: Terminated
Initiation date: 2020-08-06
Report date: 2020-09-02
Termination date: 2022-01-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Badepalle, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2020