FDA recall D-1290-2020

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.

Reason for recall

Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.

Distribution

Nationwide within the US.

Key facts

Status
Terminated
Initiation date
2020-05-28
Report date
2020-06-17
Termination date
2021-05-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1290-2020