FDA Drug recall D-0983-2015
Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle
- FDA Drug
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle by Romark Laboratories L C, citing failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0983-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-24 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Romark Laboratories L C |
| Distribution | US |
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
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Identifiers
| code_info | Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0983-2015%22
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