Good Neighbor Pharmacy All Day Allergy Tablet, Film Coated
FDA Recall NDC 24385-998

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 Good Neighbor Pharmacy All Day Allergy (NDC 24385-998). A significant event, classified as Class III, was initiated on Sep 28, 2015 by Amerisource Bergen. 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.

Reported Recall Events

September 2015 Class III Recall: Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester

Recall Number
Class III Terminated
Reason for Recall
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Initiated
Sep 28, 2015
Reported
Dec 30, 2015
Quantity
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
41163-458-39Good Neighbor Pharmacy All Day Allergy
41163-458-66Good Neighbor Pharmacy All Day Allergy
41163-458-72Good Neighbor Pharmacy All Day Allergy
41163-458-76Good Neighbor Pharmacy All Day Allergy
41163-458-95Good Neighbor Pharmacy All Day Allergy
41163-458-58Good Neighbor Pharmacy All Day Allergy
24385-998-74Good Neighbor Pharmacy All Day Allergy
24385-998-65Good Neighbor Pharmacy All Day Allergy
24385-998-75Good Neighbor Pharmacy All Day Allergy
24385-998-58Good Neighbor Pharmacy All Day Allergy
55910-699-66Good Neighbor Pharmacy All Day Allergy
42507-458-30Good Neighbor Pharmacy All Day Allergy
42507-458-39Good Neighbor Pharmacy All Day Allergy
42507-458-66Good Neighbor Pharmacy All Day Allergy
42507-458-60Good Neighbor Pharmacy All Day Allergy
42507-458-72Good Neighbor Pharmacy All Day Allergy
42507-458-45Good Neighbor Pharmacy All Day Allergy
42507-458-95Good Neighbor Pharmacy All Day Allergy
42507-458-90Good Neighbor Pharmacy All Day Allergy
42507-458-75Good Neighbor Pharmacy All Day Allergy
42507-458-06Good Neighbor Pharmacy All Day Allergy
42507-458-00Good Neighbor Pharmacy All Day Allergy
42507-458-87Good Neighbor Pharmacy All Day Allergy
59779-458-13Good Neighbor Pharmacy All Day Allergy
59779-458-39Good Neighbor Pharmacy All Day Allergy
59779-458-95Good Neighbor Pharmacy All Day Allergy
59779-458-75Good Neighbor Pharmacy All Day Allergy
59779-458-76Good Neighbor Pharmacy All Day Allergy
59779-458-88Good Neighbor Pharmacy All Day Allergy
59779-458-66Good Neighbor Pharmacy All Day Allergy
59779-458-72Good Neighbor Pharmacy All Day Allergy
59779-458-70Good Neighbor Pharmacy All Day Allergy
59779-458-58Good Neighbor Pharmacy All Day Allergy
59779-458-06Good Neighbor Pharmacy All Day Allergy
59779-458-00Good Neighbor Pharmacy All Day Allergy
59779-458-05Good Neighbor Pharmacy All Day Allergy
59779-458-01Good Neighbor Pharmacy All Day Allergy
36800-458-13Good Neighbor Pharmacy All Day Allergy
36800-458-66Good Neighbor Pharmacy All Day Allergy
36800-458-39Good Neighbor Pharmacy All Day Allergy
36800-458-95Good Neighbor Pharmacy All Day Allergy
36800-458-72Good Neighbor Pharmacy All Day Allergy
36800-458-75Good Neighbor Pharmacy All Day Allergy
36800-458-47Good Neighbor Pharmacy All Day Allergy
36800-458-87Good Neighbor Pharmacy All Day Allergy
36800-458-06Good Neighbor Pharmacy All Day Allergy
36800-458-58Good Neighbor Pharmacy All Day Allergy
37808-458-66Good Neighbor Pharmacy All Day Allergy
3700306594Good Neighbor Pharmacy All Day Allergy
49738-458-66Good Neighbor Pharmacy All Day Allergy
30142-458-66Good Neighbor Pharmacy All Day Allergy
49781-106-14Good Neighbor Pharmacy All Day Allergy
55316-458-66Good Neighbor Pharmacy All Day Allergy
21130-458-66Good Neighbor Pharmacy All Day Allergy
0363-0495-66Good Neighbor Pharmacy All Day Allergy
46994-458-66Good Neighbor Pharmacy All Day Allergy
41520-458-66Good Neighbor Pharmacy All Day Allergy
41190-458-66Good Neighbor Pharmacy All Day Allergy
0411902233Good Neighbor Pharmacy All Day Allergy
37012-458-66Good Neighbor Pharmacy All Day Allergy
3700306776Good Neighbor Pharmacy All Day Allergy
55312-458-66Good Neighbor Pharmacy All Day Allergy
0154001210Good Neighbor Pharmacy 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.