Recall Enforment Report D-0347-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Perrigo Company PLC, originally initiated on 07-27-2021 for the product Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8 The product was recalled due to failed impurities/degradation specifications; out of specification result obtained for impurity a during stability testing.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0347-202207-27-202101-12-2022Class II79,776 containersRite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0352-202207-27-202101-12-2022Class II14,160 containersWal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic,Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0333-202207-27-202101-12-2022Class II7,670 containersberkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0342-202207-27-202101-12-2022Class II65,796 containersMAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0350-202207-27-202101-12-2022Class II13,656 containersTopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic,Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0336-202207-27-202101-12-2022Class II24,912 containersDG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0329-202207-27-202101-12-2022Class II36,048 containersGoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0354-202207-27-202101-12-2022Class II38,352 bottlesamazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0349-202207-27-202101-12-2022Class II26,304 containersTopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0330-202207-27-202101-12-2022Class II32,232 containersamazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0344-202207-27-202101-12-2022Class II2280 containersallergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lakeland, FL 33811, Made in the Czech RepublicFailed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0345-202207-27-202101-12-2022Class II89,664 containersPerrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0331-202207-27-202101-12-2022Class II28,320 containersbasic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0338-202207-27-202101-12-2022Class II6,960 containersHealth Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0328-202207-27-202101-12-2022Class II55,032 unitsEQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0356-202207-27-202101-12-2022Class II2,784 bottlesCVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0334-202207-27-202101-12-2022Class II28776 containersCAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech RepublicFailed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0346-202207-27-202101-12-2022Class II41,472 containersPerrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0332-202207-27-202101-12-2022Class II62,568 containersbasic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0348-202207-27-202101-12-2022Class II44,688 containersRite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0357-202207-27-202101-12-2022Class II3,168 bottlesGoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30,Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0335-202207-27-202101-12-2022Class II138,144 containersCVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, Made in Czech RepublicFailed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0353-202207-27-202101-12-2022Class II4,536 containersWal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0339-202207-27-202101-12-2022Class II26,304 containersH.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0340-202207-27-202101-12-2022Class II13,920 containersH.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic,Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0337-202207-27-202101-12-2022Class II12,384 containersHealth Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0343-202207-27-202101-12-2022Class II4536 containersMeijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made in the Czech Republic, Distributed by Meijer Distribution Inc, Grand Rapids, MI 49544.Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0355-202207-27-202101-12-2022Class II42,026 containersKIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0341-202207-27-202101-12-2022Class II48,816 containersKroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated
D-0351-202207-27-202101-12-2022Class II7,272 containersup&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Republic,Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
11822-0425Allergy Relief Fexofenadine HydrochlorideTablet, Film CoatedOralRite Aid CorporationHuman Otc Drug
11822-0571Allergy Relief Fexofenadine HydrochlorideTablet, Film CoatedOralRite Aid CorporationHuman Otc Drug
37808-425Allergy Relief Fexofenadine HclTablet, Film CoatedOralH E BHuman Otc Drug
37808-571Allergy Relief Fexofenadine HydrochlorideTablet, Film CoatedOralH E BHuman Otc Drug
41520-229Careone Allergy Relief Fexofenadine HclTablet, Film CoatedOralAmerican Sales CompanyHuman Otc Drug
56062-571Allergy Relief Fexofenadine HclTablet, Film CoatedOralPublix Super Markets IncHuman Otc Drug
59779-425Allergy Relief Fexofenadine HclTablet, Film CoatedOralCvs PharmacyHuman Otc Drug
62011-0233Health Mart Fexofenadine Hydrochloride Fexofenadine HclTablet, Film CoatedOralStrategic Sourcing Services LlcHuman Otc Drug
62011-0413Health Mart Fexofenadine Hydrochloride Fexofenadine HydrochlorideTablet, Film CoatedOralStrategic Sourcing Services LlcHuman Otc Drug