Allergy Relief Tablet, Film Coated
FDA Recall NDC 59779-458
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 Allergy Relief (NDC 59779-458). A significant event, classified as Class III, was initiated on Sep 28, 2015 by Cvs Pharmacy. 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
41163-458-39Allergy Relief Indoor And Outdoor Allergies
41163-458-66Allergy Relief Indoor And Outdoor Allergies
41163-458-72Allergy Relief Indoor And Outdoor Allergies
41163-458-76Allergy Relief Indoor And Outdoor Allergies
41163-458-95Allergy Relief Indoor And Outdoor Allergies
41163-458-58Allergy Relief Indoor And Outdoor Allergies
24385-998-74Allergy Relief Indoor And Outdoor Allergies
24385-998-65Allergy Relief Indoor And Outdoor Allergies
24385-998-75Allergy Relief Indoor And Outdoor Allergies
24385-998-58Allergy Relief Indoor And Outdoor Allergies
55910-699-66Allergy Relief Indoor And Outdoor Allergies
42507-458-30Allergy Relief Indoor And Outdoor Allergies
42507-458-39Allergy Relief Indoor And Outdoor Allergies
42507-458-66Allergy Relief Indoor And Outdoor Allergies
42507-458-60Allergy Relief Indoor And Outdoor Allergies
42507-458-72Allergy Relief Indoor And Outdoor Allergies
42507-458-45Allergy Relief Indoor And Outdoor Allergies
42507-458-95Allergy Relief Indoor And Outdoor Allergies
42507-458-90Allergy Relief Indoor And Outdoor Allergies
42507-458-75Allergy Relief Indoor And Outdoor Allergies
42507-458-06Allergy Relief Indoor And Outdoor Allergies
42507-458-00Allergy Relief Indoor And Outdoor Allergies
42507-458-87Allergy Relief Indoor And Outdoor Allergies
59779-458-13Allergy Relief Indoor And Outdoor Allergies
59779-458-39Allergy Relief Indoor And Outdoor Allergies
59779-458-95Allergy Relief Indoor And Outdoor Allergies
59779-458-75Allergy Relief Indoor And Outdoor Allergies
59779-458-76Allergy Relief Indoor And Outdoor Allergies
59779-458-88Allergy Relief Indoor And Outdoor Allergies
59779-458-66Allergy Relief Indoor And Outdoor Allergies
59779-458-72Allergy Relief Indoor And Outdoor Allergies
59779-458-70Allergy Relief Indoor And Outdoor Allergies
59779-458-58Allergy Relief Indoor And Outdoor Allergies
59779-458-06Allergy Relief Indoor And Outdoor Allergies
59779-458-00Allergy Relief Indoor And Outdoor Allergies
59779-458-05Allergy Relief Indoor And Outdoor Allergies
59779-458-01Allergy Relief Indoor And Outdoor Allergies
36800-458-13Allergy Relief Indoor And Outdoor Allergies
36800-458-66Allergy Relief Indoor And Outdoor Allergies
36800-458-39Allergy Relief Indoor And Outdoor Allergies
36800-458-95Allergy Relief Indoor And Outdoor Allergies
36800-458-72Allergy Relief Indoor And Outdoor Allergies
36800-458-75Allergy Relief Indoor And Outdoor Allergies
36800-458-47Allergy Relief Indoor And Outdoor Allergies
36800-458-87Allergy Relief Indoor And Outdoor Allergies
36800-458-06Allergy Relief Indoor And Outdoor Allergies
36800-458-58Allergy Relief Indoor And Outdoor Allergies
37808-458-66Allergy Relief Indoor And Outdoor Allergies
3700306594Allergy Relief Indoor And Outdoor Allergies
49738-458-66Allergy Relief Indoor And Outdoor Allergies
30142-458-66Allergy Relief Indoor And Outdoor Allergies
49781-106-14Allergy Relief Indoor And Outdoor Allergies
55316-458-66Allergy Relief Indoor And Outdoor Allergies
21130-458-66Allergy Relief Indoor And Outdoor Allergies
0363-0495-66Allergy Relief Indoor And Outdoor Allergies
46994-458-66Allergy Relief Indoor And Outdoor Allergies
41520-458-66Allergy Relief Indoor And Outdoor Allergies
41190-458-66Allergy Relief Indoor And Outdoor Allergies
0411902233Allergy Relief Indoor And Outdoor Allergies
37012-458-66Allergy Relief Indoor And Outdoor Allergies
3700306776Allergy Relief Indoor And Outdoor Allergies
55312-458-66Allergy Relief Indoor And Outdoor Allergies
0154001210Allergy Relief Indoor And Outdoor Allergies
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.
