FDA recall D-1584-2019

Product

Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.

Reason for recall

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

Distribution

Nationwide within the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-02-19

Report date

2019-08-14

Termination date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1584-2019