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

FDA recall notice · announced May 13, 2015 · Romark Laboratories, L.c

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.
Quantity: 32,893 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0983-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.