FDA-Drug2015-05-13Class II
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
Romark Laboratories, L.C.
Hazard
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Sold states
Nationwide
Affected count
32,893 bottles
Manufactured in
3000 Bayport Dr Ste 200, N/A, Tampa, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0983-2015Don't want to check this manually?
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