# FDA recall D-1667-2012

> **Apotex Corp.** · Class III · drug recall initiated 2011-06-15.

## Product

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

## Reason for recall

CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1667-2012
- **Recalling firm:** Apotex Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2011-06-15
- **Report date:** 2012-09-05
- **Termination date:** 2012-09-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1667-2012

## Citation

> AI Analytics. FDA recall D-1667-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1667-2012. Source: US FDA. Licensed CC0.

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