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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4801–4820 of 17,755 recalls

Class IITerminated

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,

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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,

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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,

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

July 27, 2021 · DrugView details →

Class IITerminated

Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4

High Performance Formulas, L.L.C. (HPF, L.L.C.)

Marketed Without an Approved NDA/ANDA

July 26, 2021 · DrugView details →

Class IITerminated

PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161

Professional Disposables International, Inc

SubPotent: Out of Specification

July 23, 2021 · DrugView details →

Class IITerminated

PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.

Professional Disposables International, Inc

SubPotent: Out of Specification

July 23, 2021 · DrugView details →

Class IITerminated

PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154

Professional Disposables International, Inc

SubPotent: Out of Specification

July 23, 2021 · DrugView details →

Class IITerminated

PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185

Professional Disposables International, Inc

SubPotent: Out of Specification

July 23, 2021 · DrugView details →

Class IITerminated

PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,

Professional Disposables International, Inc

SubPotent: Out of Specification

July 23, 2021 · DrugView details →

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