All Day Allergy Tablet, Film Coated
FDA Recall NDC 42507-458
Latest: Class III · Status: Terminated · Initiated Sep 28, 2015 · 1 enforcement report
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
41163-458-39All Day Allergy
41163-458-66All Day Allergy
41163-458-72All Day Allergy
41163-458-76All Day Allergy
41163-458-95All Day Allergy
41163-458-58All Day Allergy
24385-998-74All Day Allergy
24385-998-65All Day Allergy
24385-998-75All Day Allergy
24385-998-58All Day Allergy
55910-699-66All Day Allergy
42507-458-30All Day Allergy
42507-458-39All Day Allergy
42507-458-66All Day Allergy
42507-458-60All Day Allergy
42507-458-72All Day Allergy
42507-458-45All Day Allergy
42507-458-95All Day Allergy
42507-458-90All Day Allergy
42507-458-75All Day Allergy
42507-458-06All Day Allergy
42507-458-00All Day Allergy
42507-458-87All Day Allergy
59779-458-13All Day Allergy
59779-458-39All Day Allergy
59779-458-95All Day Allergy
59779-458-75All Day Allergy
59779-458-76All Day Allergy
59779-458-88All Day Allergy
59779-458-66All Day Allergy
59779-458-72All Day Allergy
59779-458-70All Day Allergy
59779-458-58All Day Allergy
59779-458-06All Day Allergy
59779-458-00All Day Allergy
59779-458-05All Day Allergy
59779-458-01All Day Allergy
36800-458-13All Day Allergy
36800-458-66All Day Allergy
36800-458-39All Day Allergy
36800-458-95All Day Allergy
36800-458-72All Day Allergy
36800-458-75All Day Allergy
36800-458-47All Day Allergy
36800-458-87All Day Allergy
36800-458-06All Day Allergy
36800-458-58All Day Allergy
37808-458-66All Day Allergy
3700306594All Day Allergy
49738-458-66All Day Allergy
30142-458-66All Day Allergy
49781-106-14All Day Allergy
55316-458-66All Day Allergy
21130-458-66All Day Allergy
0363-0495-66All Day Allergy
46994-458-66All Day Allergy
41520-458-66All Day Allergy
41190-458-66All Day Allergy
0411902233All Day Allergy
37012-458-66All Day Allergy
3700306776All Day Allergy
55312-458-66All Day Allergy
0154001210All Day Allergy
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.
