# FDA recall D-1115-2015

> **Sandoz, Inc** · Class III · drug recall initiated 2015-04-15.

## Product

Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06

## Reason for recall

Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1115-2015
- **Recalling firm:** Sandoz, Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-15
- **Report date:** 2015-06-10
- **Termination date:** 2016-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1115-2015

## Citation

> AI Analytics. FDA recall D-1115-2015. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1115-2015. Source: US FDA. Licensed CC0.

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