Drug recall D-0525-2016
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 brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026)
Reason for recall
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Lots and codes
Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377
Recall details
- Recalling firm
- Perrigo Company PLC, Allegan, MI
- Quantity
- 209,256 cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 28, 2015
- Terminated
- March 22, 2016
Related products
- Equaline all day allergy – drug information
- NDC 36800-458 TopCare All Day Allergy · Cetirizine Hydrochloride 10 mg/1 · Topco Associates LLC
- NDC 41163-458 Equaline all day allergy · Cetirizine Hydrochloride 10 mg/1 · United Natural Foods, Inc. dba UNFI
- NDC 55910-699 rexall all day allergy relief · Cetirizine Hydrochloride 10 mg/1 · Dolgencorp, LLC
- NDC 42507-458 All Day Allergy · Cetirizine Hydrochloride 10 mg/1 · HyVee Inc
- NDC 24385-998 good neighbor pharmacy all day allergy · Cetirizine Hydrochloride 10 mg/1 · Amerisource Bergen
- NDC 59779-458 Allergy Relief Indoor and Outdoor Allergies · Cetirizine Hydrochloride 10 mg/1 · CVS Pharmacy