# FDA recall D-0525-2016

> **Perrigo Company PLC** · Class III · drug recall initiated 2015-09-28.

## Product

Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care

## Reason for recall

Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0525-2016
- **Recalling firm:** Perrigo Company PLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-28
- **Report date:** 2015-12-30
- **Termination date:** 2016-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allegan, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2016

## Citation

> AI Analytics. FDA recall D-0525-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0525-2016. Source: US FDA. Licensed CC0.

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