# FDA recall D-1278-2015

> **Purdue Pharma L.P.** · Class III · drug recall initiated 2015-07-13.

## Product

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

## Reason for recall

Failed dissolution specifications

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1278-2015
- **Recalling firm:** Purdue Pharma L.P.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-13
- **Report date:** 2015-07-29
- **Termination date:** 2017-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stamford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1278-2015

## Citation

> AI Analytics. FDA recall D-1278-2015. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1278-2015. Source: US FDA. Licensed CC0.

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