# FDA recall D-0233-2016

> **Par Pharmaceutical Inc.** · Class III · drug recall initiated 2015-10-26.

## Product

Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for impurities.

## Distribution

U.S. Nationwide including Puerto Rico

## Key facts

- **Recall number:** D-0233-2016
- **Recalling firm:** Par Pharmaceutical Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-26
- **Report date:** 2015-11-25
- **Termination date:** 2017-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Spring Valley, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2016

## Citation

> AI Analytics. FDA recall D-0233-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0233-2016. Source: US FDA. Licensed CC0.

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