DrugNov 27, 2019
Altaire Pharmaceuticals OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic recall — FDA D-0443-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
November 2019 recalls — page 11
These records include useful source details for the selected month.
DrugNov 27, 2019
Altaire Pharmaceuticals Equate Support Advanced Lubricating Eye Drops, Preservative Free recall — FDA D-0370-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF recall — FDA D-0438-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size recall — FDA D-0399-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL) recall — FDA D-0448-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution recall — FDA D-0442-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack recall — FDA D-0479-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item# recall — FDA D-0406-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE Altaire Fluorescein Sodium with recall — FDA D-0422-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Washington Homeopathic Products Calcarea Fluorica 6X Tablets, 300-count bottle, 30g recall — FDA D-0491-2020
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class IIFDA: TerminatedWashington Homeopathic Products, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420 recall — FDA D-0456-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular recall — FDA D-0358-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL recall — FDA D-0451-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin recall — FDA D-0353-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz) recall — FDA D-0450-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Extra Strength Lubricant Gel Drops recall — FDA D-0386-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL) recall — FDA D-0380-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. recall — FDA D-0385-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle recall — FDA D-0518-2020
Presence of foreign substance: Brown/black particles found during stability testing.
Class IIFDA: TerminatedTeva Pharmaceuticals USA, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ recall — FDA D-0402-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile recall — FDA D-0383-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
Altaire Pharmaceuticals iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear recall — FDA D-0434-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
DrugNov 27, 2019
X-Gen Pharmaceuticals Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials recall — FDA D-0519-2020
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Class IIIFDA: TerminatedX-Gen Pharmaceuticals Inc.
DrugNov 27, 2019
HOMATROPINE HYDROBROMIDE OPHTHALMIC Altaire Homatropaire Homatropine Hyrdobromide Opthalmic recall — FDA D-0455-2020
Lack of Assurance of Sterility
Class IIFDA: CompletedAltaire Pharmaceuticals, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.