D-0347-2022 | 07-27-2021 | 01-12-2022 | Class II | 79,776 containers | 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 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0352-2022 | 07-27-2021 | 01-12-2022 | Class II | 14,160 containers | Wal-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-0333-2022 | 07-27-2021 | 01-12-2022 | Class II | 7,670 containers | berkley 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 01581 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0342-2022 | 07-27-2021 | 01-12-2022 | Class II | 65,796 containers | MAJOR, 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 9 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0350-2022 | 07-27-2021 | 01-12-2022 | Class II | 13,656 containers | TopCare 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-0336-2022 | 07-27-2021 | 01-12-2022 | Class II | 24,912 containers | DG/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 7 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0329-2022 | 07-27-2021 | 01-12-2022 | Class II | 36,048 containers | GoodSense 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-0354-2022 | 07-27-2021 | 01-12-2022 | Class II | 38,352 bottles | amazon 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 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0349-2022 | 07-27-2021 | 01-12-2022 | Class II | 26,304 containers | TopCare 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 3 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0330-2022 | 07-27-2021 | 01-12-2022 | Class II | 32,232 containers | amazon, 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 5 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0344-2022 | 07-27-2021 | 01-12-2022 | Class II | 2280 containers | allergyrelief, 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 Republic | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0345-2022 | 07-27-2021 | 01-12-2022 | Class II | 89,664 containers | Perrigo 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 6 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0331-2022 | 07-27-2021 | 01-12-2022 | Class II | 28,320 containers | basic+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 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0338-2022 | 07-27-2021 | 01-12-2022 | Class II | 6,960 containers | Health 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 1 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0328-2022 | 07-27-2021 | 01-12-2022 | Class II | 55,032 units | EQUALINE 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-0356-2022 | 07-27-2021 | 01-12-2022 | Class II | 2,784 bottles | CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0334-2022 | 07-27-2021 | 01-12-2022 | Class II | 28776 containers | CAREONE 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 Republic | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0346-2022 | 07-27-2021 | 01-12-2022 | Class II | 41,472 containers | Perrigo 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 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0332-2022 | 07-27-2021 | 01-12-2022 | Class II | 62,568 containers | basic+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 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0348-2022 | 07-27-2021 | 01-12-2022 | Class II | 44,688 containers | Rite 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 17011 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0357-2022 | 07-27-2021 | 01-12-2022 | Class II | 3,168 bottles | GoodSense 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-0335-2022 | 07-27-2021 | 01-12-2022 | Class II | 138,144 containers | CVS 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 Republic | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0353-2022 | 07-27-2021 | 01-12-2022 | Class II | 4,536 containers | Wal-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 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0339-2022 | 07-27-2021 | 01-12-2022 | Class II | 26,304 containers | H.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 9 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0340-2022 | 07-27-2021 | 01-12-2022 | Class II | 13,920 containers | H.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-0337-2022 | 07-27-2021 | 01-12-2022 | Class II | 12,384 containers | Health 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 3 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0343-2022 | 07-27-2021 | 01-12-2022 | Class II | 4536 containers | Meijer 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-0355-2022 | 07-27-2021 | 01-12-2022 | Class II | 42,026 containers | KIRKLAND 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 4 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0341-2022 | 07-27-2021 | 01-12-2022 | Class II | 48,816 containers | Kroger 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 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Terminated |
D-0351-2022 | 07-27-2021 | 01-12-2022 | Class II | 7,272 containers | up&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 |