D-0983-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2015
- Initiation Date
- April 24, 2015
- Termination Date
- October 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,893 bottles
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.