Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
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)
Compare with the code on your package — it is the most precise check available.
Drug: Cetirizine Category: Allergy & Cold Medication
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| good neighbor pharmacy all day allergy Cetirizine Hydrochloride NDC 24385-0998 |
10 mg/1 | Tablet, Film Coated Oral |
Amerisource Bergen | OTC |
| TopCare All Day Allergy Cetirizine Hydrochloride NDC 36800-0458 |
10 mg/1 | Tablet, Film Coated Oral |
Topco Associates LLC | OTC |
| Equaline all day allergy Cetirizine Hydrochloride NDC 41163-0458 |
10 mg/1 | Tablet, Film Coated Oral |
United Natural Foods, Inc. dba UNFI | OTC |
| All Day Allergy Cetirizine Hydrochloride NDC 42507-0458 |
10 mg/1 | Tablet, Film Coated Oral |
HyVee Inc | OTC |
| rexall all day allergy relief Cetirizine Hydrochloride NDC 55910-0699 |
10 mg/1 | Tablet, Film Coated Oral |
Dolgencorp, LLC | OTC |
| Allergy Relief Indoor and Outdoor Allergies Cetirizine Hydrochloride NDC 59779-0458 |
10 mg/1 | Tablet, Film Coated Oral |
CVS Pharmacy | OTC |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Tablet/Capsules Imprinted with Wrong ID
Tablet/Capsules Imprinted with Wrong ID
CGMP Deviations
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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