# FDA recall D-0983-2015

> **Romark Laboratories, L.C.** · Class II · drug recall initiated 2015-04-24.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0983-2015
- **Recalling firm:** Romark Laboratories, L.C.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-24
- **Report date:** 2015-05-13
- **Termination date:** 2016-10-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0983-2015

## Citation

> AI Analytics. FDA recall D-0983-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0983-2015. Source: US FDA. Licensed CC0.

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