Drug 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
D-0983-2015
Product summary
- Event
- Event 70914
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,893 bottles
- Official record key
drug-enforcement:D-0983-2015
Official wording
Reason: Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Code information: Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications