FDA Drug Class II — Moderate

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

Hazard

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

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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. Suit
Brand
Romark Laboratories, L.C.
UPC
Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.

Units Affected

32,893 bottles

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