FDA recall D-0983-2015

Product

Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607

Reason for recall

Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-04-24

Report date

2015-05-13

Termination date

2016-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0983-2015