All Day Allergy Tablet, Film Coated
FDA Recall NDC 42507-458
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with All Day Allergy (NDC 42507-458). A significant event, classified as Class III, was initiated on Sep 28, 2015 by Hyvee Inc. The reported reason for this action was: "Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2015 Class III Recall: Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Recall Number
Class III Terminated
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Sep 28, 2015
Dec 30, 2015
209,256 cartons
Recall Profile & Regulatory Data
Event ID
72505
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Perrigo Company PLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 22, 2016
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)
Batch or Lot Expiration Information
Batch# Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377
Affected Packages Involved in this Recall
41163-458-39Product
41163-458-66Product
41163-458-72Product
41163-458-76Product
41163-458-95Product
41163-458-58Product
24385-998-74Product
24385-998-65Product
24385-998-75Product
24385-998-58Product
55910-699-66Product
42507-458-30Product
42507-458-39Product
42507-458-66Product
42507-458-60Product
42507-458-72Product
42507-458-45Product
42507-458-95Product
42507-458-90Product
42507-458-75Product
42507-458-06Product
42507-458-00Product
42507-458-87Product
59779-458-13Product
59779-458-39Product
59779-458-95Product
59779-458-75Product
59779-458-76Product
59779-458-88Product
59779-458-66Product
59779-458-72Product
59779-458-70Product
59779-458-58Product
59779-458-06Product
59779-458-00Product
59779-458-05Product
59779-458-01Product
36800-458-13Product
36800-458-66Product
36800-458-39Product
36800-458-95Product
36800-458-72Product
36800-458-75Product
36800-458-47Product
36800-458-87Product
36800-458-06Product
36800-458-58Product
37808-458-66Product
3700306594Product
49738-458-66Product
30142-458-66Product
49781-106-14Product
55316-458-66Product
21130-458-66Product
0363-0495-66Product
46994-458-66Product
41520-458-66Product
41190-458-66Product
0411902233Product
37012-458-66Product
3700306776Product
55312-458-66Product
0154001210Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
