Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
What was recalled
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
- Recalling firm
- Romark Laboratories, L.C.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0983-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.