Why it was recalled
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Product description
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)
Lot numbers, UPCs & expiration codes
Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0525-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 28, 2015
- FDA report date
- Dec 30, 2015
- Quantity
- 209,256 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0525-2016, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 72505
- Address
- 515 Eastern Ave
- Code information
- Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377
- Postal code
- 49010-9070
- Report date
- Dec 30, 2015
- Product type
- Drugs
- Recall number
- D-0525-2016
- Classification
- Class III
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 209,256 cartons
- Termination date
- Mar 22, 2016
- Reason for recall
- Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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)
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 24, 2015