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