FDA Recall Good Neighbor Pharmacy All Day Allergy

The most recent Recall Enforcement Report that covers this product was initiated on September 28th, 2015 and classified as a Class III recall due to failed impurity/degradations specifications; impurity identified as cetirizine monosaccharide ester This recall is currently terminated, and the associated recall number is recall number is D-0525-2016. It pertains to Good Neighbor Pharmacy All Day Allergy identified by 24385-998 as of 03-22-2016 .

Recall Number D-0525-2016

Event ID

72505 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-0525-2016 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

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)

Reason For Recall

Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

209,256 cartons Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

12-30-2015

Recall Initiation Date

09-28-2015 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Termination Date

03-22-2016 What is the Date Terminated?
The date that FDA terminated the recall.

Initial Firm Notification

Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

Perrigo Company PLC

Code Info/dt>

Batches: Exp 05/16: 4GE1457; 4GE1500; 4GE1819; 4GE1893; 4HE1255; 4HE1396; 4HE1620; 4HE1656; 4HE1811; 4JE1035; 4JE1212; 4JE1324; 4JE1513; and 4KE1377 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

41163-458-39; 41163-458-66; 41163-458-72; 41163-458-76; 41163-458-95; 41163-458-58; 24385-998-74; 24385-998-65; 24385-998-75; 24385-998-58; 55910-699-66; 59779-458-13; 59779-458-39; 59779-458-95; 59779-458-75; 59779-458-76; 59779-458-88; 59779-458-66; 59779-458-72; 59779-458-70; 59779-458-58; 59779-458-06; 59779-458-00; 36800-458-13; 36800-458-66; 36800-458-39; 36800-458-95; 36800-458-72; 36800-458-75; 36800-458-47; 36800-458-87; 36800-458-06; 36800-458-58; 37808-458-66; 3700306594; 42507-458-66; 49738-458-66; 30142-458-66; 49781-106-14; 55316-458-66; 21130-458-66; 0363-0495-66; 46994-458-66; 41520-458-66; 41190-458-66; 0411902233; 37012-458-66; 3700306776; 55312-458-66; 0154001210

Status

Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.