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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 February 2, 2022 Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single… Lack of Assurance of Sterility. Edge Pharma, LLC Terminated
Class II February 2, 2022 Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free,… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL),… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per… Failed Dissolution Specifications. Ascend Laboratories, LLC Terminated
Class II February 2, 2022 Pioglitazone Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA,… Superpotent and Failed Tablet/Capsule Specifications Aurobindo Pharma USA Inc. Terminated
Class II February 2, 2022 Metformin Hydrochloride Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC#… CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. VIONA PHARMACEUTICALS INC Terminated
Class II February 2, 2022 Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only,… Failed Dissolution Specifications American Health Packaging Terminated
Class II February 2, 2022 PROCTOFOAM Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol,… cGMP deficiencies Mylan Pharmaceuticals Inc Terminated
Class III January 26, 2022 Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III January 26, 2022 CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II January 26, 2022 Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100… CGMP Deviations Ingenus Pharmaceuticals Llc Terminated
Class I January 26, 2022 Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC… Labeling: Missing Label: label missing from some Semglee prefilled pens. Mylan Pharmaceuticals Inc Terminated
Class III January 26, 2022 Fexofenadine HCl and Pseudoephedrine HCI Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II January 26, 2022 Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets,… CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under… Medique Products Terminated
Class III January 26, 2022 Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III January 26, 2022 Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II January 26, 2022 Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets,… CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under… Medique Products Terminated
Class II January 26, 2022 Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and… CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under… Medique Products Terminated
Class III January 26, 2022 Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in… Subpotent drug Dr. Reddy's Laboratories, Inc. Terminated
Class I January 26, 2022 SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg… Microbial Contamination of Non-Sterile Product Lohxa, LLC Terminated
Class III January 26, 2022 QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III January 26, 2022 Fexofenadine HCl and Pseudoephedrine HCI Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II January 26, 2022 Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed… CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. Mayne Pharma Inc Ongoing
Class II January 26, 2022 Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC… Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the… Teva Pharmaceuticals USA Terminated
Class III January 26, 2022 Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II January 26, 2022 Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm,… Failed Stability Specifications VistaPharm, Inc. Terminated
Class III January 26, 2022 equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl… Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II January 19, 2022 The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL)… Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132… Revive Personal Products Company Ongoing
Class II January 19, 2022 Metformin 750 mg Extended Release NDC # 70518-2920-00 CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. RemedyRepack Inc. Terminated
Class II January 19, 2022 Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural… Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. Akorn, Inc. Terminated
Class II January 19, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only,… Lack of Assurance of Sterility Exela Pharma Sciences LLC Terminated
Class III January 19, 2022 Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx… Labeling: Missing Label Akorn, Inc. Terminated
Class II January 19, 2022 NITROGLYCERIN LINGUAL Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx… Defective Delivery System Padagis US LLC Terminated
Class III January 19, 2022 Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech… Labeling: Missing Label Akorn, Inc. Terminated
Class II January 19, 2022 Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II January 19, 2022 MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II January 19, 2022 Metoprolol Tartrate Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by:… Complaint received of foreign matter (metal) embedded in tablet. Rubicon Research Private Limited Terminated
Class I January 19, 2022 Clobetasol Propionate Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro… Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II January 19, 2022 Carbamazepine Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by:… Failed Dissolution Specifications Torrent Pharma Inc. Terminated
Class III January 12, 2022 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin… Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay… Lupin Pharmaceuticals Inc. Terminated
Class II January 12, 2022 Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC… CGMP Deviations: failed stability results, inadequate laboratory investigations ULTRAtab Laboratories, Inc. Terminated
Class II January 12, 2022 Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count… Failed Impurities/Degradation Specifications RemedyRepack Inc. Terminated
Class II January 12, 2022 DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 CEFIXIME Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories… Failed impurities/degradation specifications Ascend Laboratories, LLC Terminated
Class II January 12, 2022 Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 CareOne Allergy Relief CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Pregabalin Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical… Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II January 12, 2022 Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class II January 12, 2022 Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine,… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability… Perrigo Company PLC Terminated
Class III January 12, 2022 Oxycodone Hydrochloride Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured… Out-of-specification impurity test result observed at 18-month long term stability time point. Lupin Pharmaceuticals Inc. Terminated
Class II January 5, 2022 PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL),… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx… Lack of Assurance of Sterility SterRx, LLC Terminated
Class I January 5, 2022 Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in… Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and… Aroma Release Technologies Inc Terminated
Class I January 5, 2022 kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles,… Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and… Valisa MFG LLC Terminated
Class II January 5, 2022 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only,… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II January 5, 2022 Lidocaine Hydrochloride Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap… Superpotent Drug: Minimally superpotent Teligent Pharma, Inc. Ongoing
Class I January 5, 2022 Lidocaine Hydrochloride Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap… Superpotent Drug Teligent Pharma, Inc. Ongoing
Class II January 5, 2022 Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only,… Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle… Teligent Pharma, Inc. Terminated
Class I January 5, 2022 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured… Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates. Gilead Sciences, Inc. Terminated
Class II December 29, 2021 Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04… Microbial Contamination of Non-Sterile Products Efficient Laboratories, Inc. Terminated
Class II December 29, 2021 Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC… Defective Container: Customer complaints for leaking bottles and dispensing issues. Medline Industries Inc Terminated
Class II December 29, 2021 Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major… Failed Impurities/Degradation Specifications The Harvard Drug Group Terminated
Class II December 29, 2021 Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10… Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL Denver Solutions, LLC DBA Leiters Health Terminated
Class II December 29, 2021 Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC… Subpotent Teva Pharmaceuticals USA Terminated
Class II December 29, 2021 Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed… Microbial Contamination of Non-Sterile Products Efficient Laboratories, Inc. Terminated
Class II December 29, 2021 Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by:… Microbial Contamination of Non-Sterile Products Efficient Laboratories, Inc. Terminated
Class II December 29, 2021 Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc.… Microbial Contamination of Non-Sterile Products Efficient Laboratories, Inc. Terminated
Class II December 22, 2021 Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire… Lack of Processing Controls Valgene Incorporated dba Cape Drugs Terminated
Class II December 22, 2021 Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg:… Defective container: Out of specification for container integrity leading to bottles leaking. Preferred Pharmaceuticals, Inc. Ongoing
Class II December 22, 2021 B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road… Lack of Processing Controls Valgene Incorporated dba Cape Drugs Terminated
Class II December 22, 2021 Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort… Superpotent Drug TOLMAR, Inc. Terminated
Class III December 22, 2021 Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx… Superpotent; Hydrochlorothiazide Torrent Pharma Inc. Terminated
Class II December 22, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only,… CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the… Teligent Pharma, Inc. Terminated
Class I December 22, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only,… Superpotent Drug Teligent Pharma, Inc. Terminated
Class II December 22, 2021 Lidocaine Hydrochloride Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only,… CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the… Teligent Pharma, Inc. Terminated
Class III December 15, 2021 Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II December 15, 2021 VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use… Crystallization: Product appears to be turbid. Apollo Care Terminated
Class III December 15, 2021 Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP,… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III December 15, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class I December 15, 2021 AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E &… Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. American Screening LLC Completed
Class III December 15, 2021 Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy &… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III December 15, 2021 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III December 15, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III December 15, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III December 15, 2021 Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class III December 15, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II December 15, 2021 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx… Product Mix-up Ascent Pharmaceuticals, Inc. Terminated
Class II December 8, 2021 Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or… Lack of Assurance of Sterility ASP CARES Terminated
Class III December 8, 2021 Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03… Subpotent Drug Lupin Pharmaceuticals Inc. Terminated
Class II December 8, 2021 Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or… Lack of Assurance of Sterility ASP CARES Terminated
Class II December 8, 2021 Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV… Lack of Assurance of Sterility ASP CARES Terminated
Class I December 8, 2021 Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic… Temperature Abuse; temperature excursion during shipping Sandoz Inc Completed
Class II December 8, 2021 Dextrose 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira,… Lack of sterility assurance: bag has the potential to leak. Pfizer Inc. Terminated
Class III December 1, 2021 Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC:… Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals Ongoing
Class III December 1, 2021 Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:… Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals Ongoing
Class II December 1, 2021 Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx… Defective Container Teligent Pharma, Inc. Terminated
Class III December 1, 2021 Carvedilol Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo… Failed Impurities/Degradation Specifications Aurobindo Pharma USA Inc. Terminated
Class II December 1, 2021 Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx… Defective Container Teligent Pharma, Inc. Terminated
Class III December 1, 2021 topiramate Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem… Discoloration UNICHEM PHARMACEUTICALS USA INC Terminated
Class II November 24, 2021 Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle,… Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Amneal Pharmaceuticals of New York, LLC Terminated
Class II November 24, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class I November 24, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can,… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class I November 24, 2021 LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by:… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class III November 24, 2021 Clonidine transdermal system Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured… Failed Impurities/Degradation Specifications Teva Pharmaceuticals USA Terminated
Class I November 24, 2021 Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ)… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class I November 24, 2021 Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class I November 24, 2021 LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can,… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class I November 24, 2021 Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle,… Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Amneal Pharmaceuticals of New York, LLC Terminated
Class II November 24, 2021 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ)… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a)… cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ)… cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be… Bayer Healthcare Pharmaceuticals Inc. Terminated
Class I November 24, 2021 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class I November 24, 2021 Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ)… Chemical Contamination: presence of benzene Bayer Healthcare Pharmaceuticals Inc. Terminated
Class II November 24, 2021 Cartia Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90… Labelling: Incorrect Exp. Date Teva Pharmaceuticals USA Terminated
Class II November 17, 2021 ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.25MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.75MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRIMTROPIC - MIC B COMPLEX/CHROM/CARN 20MG/40MG/50MG/5MG/33MG/2MG/1MG/25MCG/25MG… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/ML INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.5/PGE-1 5 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MIC B COMPLEX W CHROMIUM/ METHYLCOB (BOYDEN) INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, Rx only, Talon Compounding Pharmacy,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ **T 101** INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 Tadalafil Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx… Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II November 17, 2021 B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 HYDROXOCOBALAMIN 5,000MCG/ML INJ 5,000MCG/ML INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 (WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.25MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML+LIDO 20/40/50/25/25MG/ML+LIDO INJECTABLE,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 ALPROSTADIL 45MCG/ML 45MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 15/PHENTOLAMINE 1/PGE-1 10 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 18/PHENTOL 0.6/PGE-1 6/ML INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 25MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 30MG/ML #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only,… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 30/PHENTOL 3/PGE-1 100/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/ML INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 25/PHENTOLAMINE 3/PGE-1 80 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TEST CYPIONATE 200MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 IC B COMPLEX INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 PROGESTERONE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated
Class II November 17, 2021 QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ *C5* INJECTABLE, Rx only, Talon… Lack of assurance of sterility Vita Pharmacy, LLC dba Talon Compounding Pharmacy Terminated