FDA recall D-409-2014

Product

Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09

Reason for recall

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-09-17

Report date

2014-01-22

Termination date

2016-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-409-2014