FDA recall D-1250-2020

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03

Reason for recall

Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.

Distribution

Product was distributed Nationwide in the United States.

Key facts

Status
Terminated
Initiation date
2020-04-20
Report date
2020-04-29
Termination date
2021-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1250-2020