FDA recall D-498-2013

Product

Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India

Reason for recall

Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-09

Report date

2013-06-05

Termination date

2014-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-498-2013