January 12, 2022DrugsFDA
Perrigo Company PLC recalls Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by t
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle,
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckess
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesso
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by:
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle,
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czec
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Re
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in t
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22,
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated
Hazard: CGMP Deviations: failed stability results, inadequate laboratory investigations,
January 12, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Hazard: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
January 5, 2022DrugsFDA
Valisa MFG LLC recalls kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmin
Hazard: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
January 5, 2022DrugsFDA
SterRx, LLC recalls Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave.,
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave.
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsbur
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Pla
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Pla
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Pl
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave.
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave.,
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plat
Hazard: Lack of Assurance of Sterility
January 5, 2022DrugsFDA
SterRx, LLC recalls Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh
Hazard: Lack of Assurance of Sterility