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

Recall Number: D-0983-2015

Firm: Romark Laboratories, L.C.

Classification: Class II

Status: Terminated

Report Date: 20150513

Initiation Date: 20150424

Termination Date: 20161025

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

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