January 19, 2022DrugsFDA
Padagis US LLC recalls Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeru
Hazard: Defective Delivery System
January 19, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manuf
Hazard: Lack of Assurance of Sterility
January 19, 2022DrugsFDA
Teva Pharmaceuticals USA recalls MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactu
Hazard: Lack of Assurance of Sterility
January 19, 2022DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: E
Hazard: Lack of Assurance of Sterility
January 19, 2022DrugsFDA
Akorn, Inc. recalls Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pha
Hazard: Labeling: Missing Label
January 19, 2022DrugsFDA
Akorn, Inc. recalls Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityvill
Hazard: Labeling: Missing Label
January 19, 2022DrugsFDA
RemedyRepack Inc. recalls Metformin 750 mg Extended Release NDC # 70518-2920-00
Hazard: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
January 19, 2022DrugsFDA
Torrent Pharma Inc. recalls Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bha
Hazard: Failed Dissolution Specifications
January 19, 2022DrugsFDA
Revive Personal Products Company recalls The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive
Hazard: Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
January 19, 2022DrugsFDA
Rubicon Research Private Limited recalls Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; M
Hazard: Complaint received of foreign matter (metal) embedded in tablet.
January 12, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Hazard: Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
January 12, 2022DrugsFDA
RemedyRepack Inc. recalls Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03),
Hazard: Failed Impurities/Degradation Specifications
January 12, 2022DrugsFDA
Ascend Laboratories, LLC recalls Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distribut
Hazard: Failed impurities/degradation specifications
January 12, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Hazard: Out-of-specification impurity test result observed at 18-month long term stability time point.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Dis
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, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, U
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 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 amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 2
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 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 TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, ND
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 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 Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 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 Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Di
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, D
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, N
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
January 12, 2022DrugsFDA
Perrigo Company PLC recalls MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceut
Hazard: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.