Romark Laboratories, L.C. recalls Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuti…
- Recall date
- April 24, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0983-2015
- FDA classification
- Class II
- Brand / firm
- Romark Laboratories, L.C.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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
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