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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II December 11, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9%… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9%… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free,… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9%… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9%… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL)… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9%… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative… Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules QuVa Pharma, Inc. Terminated
Class II December 11, 2019 Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For… Discoloration; Hazy solution found in one vial instead of a clear solution. AuroMedics Pharma LLC Terminated
Class II December 11, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,… CGMP Deviations: Presence of NDMA impurity detected in product. Sanofi-Aventis U.S. LLC Ongoing
Class II December 11, 2019 EXPAREL EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL),… Sub Potent Drug: Out of Specification (OOS) Pacira Pharmaceuticals, Inc. Terminated
Class II December 4, 2019 Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred… Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material… Preferred Pharmaceuticals, Inc Terminated
Class III December 4, 2019 amiodarone hydrochloride Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose… Crystallization: Presence of visible particulate matter. AuroMedics Pharma LLC Terminated
Class II December 4, 2019 AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski,… CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API AVKARE Inc. Terminated
Class II December 4, 2019 Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx… CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. AuroMedics Pharma LLC Ongoing
Class II December 4, 2019 Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo… CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. AuroMedics Pharma LLC Ongoing
Class II December 4, 2019 Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo… CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. AuroMedics Pharma LLC Ongoing
Class II December 4, 2019 Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo… CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. AuroMedics Pharma LLC Ongoing
Class II December 4, 2019 DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by:… CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. AuroMedics Pharma LLC Ongoing
Class III December 4, 2019 amiodarone hydrochloride Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose… Crystallization: Presence of visible particulate matter. AuroMedics Pharma LLC Terminated
Class III December 4, 2019 amiodarone hydrochloride Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple… Crystallization: Presence of visible particulate matter. AuroMedics Pharma LLC Terminated
Class II December 4, 2019 AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN… CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API AVKARE Inc. Terminated
Class II December 4, 2019 Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution,… Lack of sterility assurance. New Vitalis Pharmacy LLC dba New Vitalis Pharmacy Terminated
Class II December 4, 2019 Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical… Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content. Avantor Performance Materials Inc Terminated
Class II December 4, 2019 Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in… Presence of Foreign Substance: Foreign material found inside the vial. AuroMedics Pharma LLC Terminated
Class II November 27, 2019 Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for:… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake Well,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x.… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in India… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for:… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively… CGMP Deviations: products were not manufactured under current good manufacturing practices. Washington Homeopathic Products, Inc. Terminated
Class II November 27, 2019 Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only,… Lack of Processing Controls Integrated Health Concepts Inc. dba Conversio Health Terminated
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc.,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 TRP/ TARGET up & up intensive relief lubricating eye drop, 10 mL Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL),… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL),… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd.… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl.… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g),… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 TRP Pink Eye Relief, 10 mL, NDC 17312-013-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc.,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz.… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5%… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item #… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl.… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for Perrigo,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 TRP Stye Relief, 4 g, NDC 17312-014-13 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, Package Size:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 TRP Blur Relief, 15 mL, NDC 17312-002-11 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL),… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7 Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item #994881… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Containers, 0.02… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by:… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 CVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed by: CVS… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Sodium Chloride 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation… Lack of Assurance of Sterility: Product has the potential to leak. Baxter Healthcare Corporation Terminated
Class II November 27, 2019 Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g,… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured… Lack of Assurance of Sterility Altaire Pharmaceuticals, Inc. Completed
Class II November 27, 2019 Valganciclovir hydrochloride for Oral Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx… Presence of foreign substance: Brown/black particles found during stability testing. Teva Pharmaceuticals USA, Inc. Terminated
Class III November 27, 2019 Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by:… Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. X-Gen Pharmaceuticals Inc. Terminated
Class II November 20, 2019 Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium… CGMP Deviations: Presence of NDMA impurity detected in product. Novitium Pharma LLC Terminated
Class II November 20, 2019 Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by:… CGMP Deviations: Presence of NDMA impurity detected in product. Lannett Company, Inc. Terminated
Class II November 20, 2019 Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer… GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Apotex Inc. Completed
Class II November 20, 2019 Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium… CGMP Deviations: Presence of NDMA impurity detected in product. Novitium Pharma LLC Terminated
Class II November 20, 2019 Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class III November 20, 2019 Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed… Subpotent Drug Sato Pharmaceutical Inc. Terminated
Class II November 20, 2019 Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class III November 20, 2019 Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato… Subpotent Drug Sato Pharmaceutical Inc. Terminated
Class II November 20, 2019 Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30… GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Apotex Inc. Completed
Class II November 20, 2019 Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets… GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Apotex Inc. Completed
Class II November 20, 2019 Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05)… CGMP Deviations: Presence of NDMA impurity detected in product. Golden State Medical Supply Inc. Terminated
Class II November 20, 2019 Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer… GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Apotex Inc. Completed
Class II November 20, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer… GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Apotex Inc. Completed
Class II November 20, 2019 Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium… CGMP Deviations: Presence of NDMA impurity detected in product. Novitium Pharma LLC Terminated
Class II November 20, 2019 Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium… CGMP Deviations: Presence of NDMA impurity detected in product. Novitium Pharma LLC Terminated
Class II November 20, 2019 Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,… Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. 8046255 Canada Inc. DBA Viatrexx Terminated
Class II November 20, 2019 GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01)… CGMP Deviations: Presence of NDMA impurity detected in product. Golden State Medical Supply Inc. Terminated
Class II November 20, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets… GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Apotex Inc. Completed
Class III November 20, 2019 WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC… Subpotent Drug Sato Pharmaceutical Inc. Terminated
Class III November 20, 2019 Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by… Subpotent Drug Sato Pharmaceutical Inc. Terminated
Class II November 20, 2019 Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL,… Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection KVK-Tech, Inc. Terminated
Class III November 20, 2019 Isotretinoin Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules… Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. Amneal Pharmaceuticals, Inc. Terminated
Class III November 13, 2019 Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for:… Presence of Foreign substance: identified as a dead ant. Lupin Pharmaceuticals Inc. Terminated
Class II November 13, 2019 S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 13, 2019 S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX. Lack of Assurance of Sterility First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 13, 2019 Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by:… Marketed without an Approved NDA/ANDA Basic Reset Inc. Terminated
Class II November 13, 2019 S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compounding Rx Lack of Assurance of Sterility First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 13, 2019 S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain… Lack of Assurance of Sterility First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 13, 2019 S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red… Lack of Assurance of Sterility First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated
Class II November 13, 2019 Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL)… Marketed without an Approved NDA/ANDA Basic Reset Inc. Terminated
Class II November 13, 2019 S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain… Lack of Assurance of Sterility First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Terminated