FDA recall D-1077-2018

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

Reason for recall

Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.

Distribution

Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.

Key facts

Status
Terminated
Initiation date
2018-08-13
Report date
2018-08-22
Termination date
2019-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1077-2018