Alinia — Class II drug recall D-0983-2015
Terminated recall by Romark Laboratories, L.C., reported 2015-05-13, distributed nationwide. Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscos
| Recall number | D-0983-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Romark Laboratories, L.C., Tampa, FL, United States |
| Recall initiated | 2015-04-24 |
| Classified | 2015-05-04 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2016-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 32,893 bottles |
| Reason classes | specification failure |
| Lot numbers | MTCW21281, MTCW21291, MTEW1721, MTEW5791, MTEW5801 |
| Expiration dates | 2016-09, 2016-12, 2017-01 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0983-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.