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
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | June 2, 2021 | RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Eletriptan hydrobromide Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Neomycin Sulfate NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Levalbuterol tartrate HFA inhalation Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | LEVOXYL LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc.… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Epinephrine EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Polyethylene Glycol 3350 Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Edarbi Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Edarbyclor edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC;… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Edarbyclor edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Banzel Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Calcium Acetate Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for:… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | SULINDAC Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX;… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Oseltamivir Phosphate for Oral Suspension Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | estradiol Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | EPIPEN Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class III | June 2, 2021 | Olmesartan Medoxomil Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem… | Presence of Foreign Tablet/Capsule | Ascend Laboratories LLC | Terminated |
| Class II | June 2, 2021 | Methotrexate Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BELSOMRA Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | TRI-LO-MARZIA TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | NARCAN Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Fenofibrate FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX;… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for:… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Triamcinolone Acetonide Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | CHANTIX Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets)… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | bupropion Hydrochloride bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Tirosint TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Daytrana Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr),… | Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer… | Noven Pharmaceuticals Inc | Ongoing |
| Class II | June 2, 2021 | Daytrana Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr),… | Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer… | Noven Pharmaceuticals Inc | Ongoing |
| Class II | June 2, 2021 | travoprost TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BELBUCA Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Spiriva Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | meloxicam Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for:… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Nuedexta Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | verapamil hydrochloride Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Amantadine Hydrochloride Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Livalo Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate,… | Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of… | Accupac, Inc. | Terminated |
| Class II | June 2, 2021 | Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Clindamycin hydrochloride CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Cefazolin Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Theophylline Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Darifenacin Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Haloperidol HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Bisoprolol Fumarate and Hydrochlorothiazide BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | PROCTOFOAM Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Namzaric Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class I | June 2, 2021 | NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles… | Subpotent Drug | Acella Pharmaceuticals, LLC | Terminated |
| Class II | June 2, 2021 | Darifenacin Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Glyxambi Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Synjardy Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc.… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Butorphanol Tartrate Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | XIGDUO xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Orilissa Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Arnuity Ellipta Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Ibuprofen IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Acetazolamide AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for:… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class I | June 2, 2021 | NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only… | Subpotent Drug | Acella Pharmaceuticals, LLC | Terminated |
| Class II | June 2, 2021 | Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | NURTEC ODT NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | lamotrigine extended release Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Pregabalin PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Linzess Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | STEGLATRO Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for:… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Penicillin V Potassium PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Trelegy Ellipta Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Childrens Loratadine Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Desvenlafaxine Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class I | June 2, 2021 | NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles… | Subpotent Drug | Acella Pharmaceuticals, LLC | Terminated |
| Class II | June 2, 2021 | Creon Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BRILINTA Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for:… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Ezetimibe and Simvastatin EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Synjardy Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class I | June 2, 2021 | NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only,… | Subpotent Drug | Acella Pharmaceuticals, LLC | Terminated |
| Class II | June 2, 2021 | Valsartan Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by:… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Briviact Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB,… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Trelegy Ellipta TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER)… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | XIGDUO xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Jentadueto XR Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class I | June 2, 2021 | NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles… | Subpotent Drug | Acella Pharmaceuticals, LLC | Terminated |
| Class II | June 2, 2021 | Nadolol Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | June 2, 2021 | Budesonide and Formoterol Fumarate Dihydrate Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80… | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. | Terminated |
| Class II | May 26, 2021 | Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC | Ongoing |
| Class III | May 26, 2021 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100… | Subpotent Drug | Nomax Inc | Terminated |
| Class II | May 26, 2021 | Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic… | CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of… | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | May 26, 2021 | Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. | Bit & Bet LLC | Terminated |
| Class II | May 26, 2021 | PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card,… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC | Ongoing |
| Class II | May 26, 2021 | PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card,… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC | Ongoing |
| Class II | May 26, 2021 | Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx… | Lack of Assurance of Sterility | Teva Pharmaceuticals USA | Terminated |
| Class II | May 26, 2021 | Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile,… | Lack of Assurance of Sterility | Teva Pharmaceuticals USA | Terminated |
| Class II | May 26, 2021 | Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile,… | Lack of Assurance of Sterility | Teva Pharmaceuticals USA | Terminated |
| Class II | May 26, 2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial,… | Lack of Assurance of Sterility | Teva Pharmaceuticals USA | Terminated |
| Class II | May 26, 2021 | CEFIXIME Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by:… | Subpotent Drug | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | May 26, 2021 | Asenapine Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC,… | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of… | SigmaPharm Laboratories LLC | Terminated |
| Class III | May 26, 2021 | Asenapine Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC,… | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of… | SigmaPharm Laboratories LLC | Terminated |
| Class III | May 26, 2021 | CEQUA Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10… | Subpotent and Presence of Particulates . | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | May 26, 2021 | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case… | Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. | Fresenius Medical Care, North America | Terminated |
| Class II | May 26, 2021 | Sterile Water Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug… | Presence of Particulate Matter: particulate matter identified as an insect in one vial. | Pfizer Inc. | Terminated |
| Class II | May 26, 2021 | metoclopramide Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA… | Lack of Assurance of Sterility | Teva Pharmaceuticals USA | Terminated |
| Class III | May 26, 2021 | Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count… | Failed Impurities/Degradation Specifications | KVK-Tech, Inc. | Terminated |
| Class I | May 19, 2021 | BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and… | Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation… | CareFusion 213, LLC | Terminated |
| Class II | May 19, 2021 | Metformin Hydrochloride Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx… | Presence of foreign substance: identified as activated carbon. | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | May 12, 2021 | Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. | Antoto-K | Terminated |
| Class I | May 12, 2021 | heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol… | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. | PNHC, LLC. | Terminated |
| Class II | May 12, 2021 | Burro en Primavera, 2 capsules, UPC 638632431055 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart | Ongoing |
| Class II | May 12, 2021 | Imperial Platinum 2000, 1 capsule, UPC 718122040702 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart | Ongoing |
| Class II | May 12, 2021 | PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart | Ongoing |
| Class II | May 12, 2021 | IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart | Ongoing |
| Class I | May 12, 2021 | Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr:… | Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in… | A-S Medication Solutions LLC. | Terminated |
| Class III | May 12, 2021 | Acyclovir Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet… | Labeling: Incorrect or Missing Lot and/or Exp Date | Heritage Pharmaceuticals Inc | Terminated |
| Class III | May 5, 2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after… | Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs… | Genentech Inc | Terminated |
| Class II | May 5, 2021 | Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | Na Na Collection | Ongoing |
| Class II | May 5, 2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas… | cGMP deviations | Grace Healthcare Medical, Inc | Terminated |
| Class II | May 5, 2021 | Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | S & B Story LLC | Ongoing |
| Class II | May 5, 2021 | PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | Namoo Enterprise LLC | Terminated |
| Class II | May 5, 2021 | PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per… | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | Na Na Collection | Ongoing |
| Class III | May 5, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes,… | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. | Terminated |
| Class III | May 5, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes,… | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. | Terminated |
| Class III | May 5, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes,… | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Teligent Pharma, Inc. | Terminated |
| Class II | May 5, 2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there… | CareFusion 213, LLC | Terminated |
| Class II | May 5, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there… | CareFusion 213, LLC | Terminated |
| Class I | May 5, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of… | CareFusion 213, LLC | Terminated |
| Class I | May 5, 2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of… | CareFusion 213, LLC | Terminated |
| Class I | May 5, 2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of… | CareFusion 213, LLC | Terminated |
| Class I | May 5, 2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of… | CareFusion 213, LLC | Terminated |
| Class II | May 5, 2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative… | CareFusion 213, LLC | Terminated |
| Class II | May 5, 2021 | Losartan Potassium Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated… | CGMP deviation: Product found to contain trace amounts of NMBA | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | May 5, 2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative… | CareFusion 213, LLC | Terminated |
| Class II | May 5, 2021 | Cephalexin Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250… | Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer… | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 28, 2021 | Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical… | Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility | Edge Pharma, LLC | Terminated |
| Class II | April 28, 2021 | Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc.… | Failed Impurities/Degradation Specifications: | Teligent Pharma, Inc. | Ongoing |
| Class II | April 28, 2021 | estradiol Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by:… | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the… | Noven Pharmaceuticals Inc | Terminated |
| Class II | April 28, 2021 | Minivelle Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only,… | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the… | Noven Pharmaceuticals Inc | Terminated |
| Class II | April 21, 2021 | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/… | CGMP Deviations | Spartan Chemical Co Inc | Terminated |
| Class I | April 21, 2021 | Tresiba TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial,… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | Tresiba TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen,… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class II | April 21, 2021 | Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant… | Failed Dissolution Specifications | Jubilant Cadista Pharmaceuticals, Inc. | Terminated |
| Class I | April 21, 2021 | Tresiba TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen,… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18… | Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans | Spartan Chemical Co Inc | Terminated |
| Class II | April 21, 2021 | foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27… | CGMP Deviations | Spartan Chemical Co Inc | Terminated |
| Class III | April 21, 2021 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma… | Failed Stability Specifications: product did not meet viscosity results. | Teligent Pharma, Inc. | Terminated |
| Class III | April 21, 2021 | Candesartan Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for:… | Failed Impurities/Degradation Specifications | Macleods Pharma Usa Inc | Terminated |
| Class II | April 21, 2021 | Cefprozil Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles… | Superpotent Drug | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | April 21, 2021 | Victoza ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class II | April 21, 2021 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US… | CGMP Deviations | Spartan Chemical Co Inc | Terminated |
| Class II | April 21, 2021 | Saxenda Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample.… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class II | April 21, 2021 | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per… | CGMP Deviations | Spartan Chemical Co Inc | Terminated |
| Class II | April 21, 2021 | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net… | CGMP Deviations | Spartan Chemical Co Inc | Terminated |
| Class I | April 21, 2021 | Fiasp Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial,… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | Fiasp Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen,… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | Fiasp Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class II | April 21, 2021 | Riomet Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473… | Microbial Contamination of Non-Sterile Product | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class III | April 21, 2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC:… | Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on… | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Ongoing |
| Class II | April 21, 2021 | OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample.… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen,… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class I | April 21, 2021 | NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial,… | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage… | Novo Nordisk Inc | Terminated |
| Class III | April 14, 2021 | LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington… | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. | Terminated |
| Class II | April 14, 2021 | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and… | CGMP Deviaitons | Cosette Pharmaceuticals, Inc. | Terminated |
| Class III | April 14, 2021 | Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R… | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. | Terminated |
| Class II | April 14, 2021 | Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only,… | Failed Impurities/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | April 14, 2021 | Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S.… | Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam… | Kimberly-Clark Corporation | Terminated |
| Class III | April 14, 2021 | Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural… | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. | Terminated |
| Class II | April 14, 2021 | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured… | Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay | X-Gen Pharmaceuticals Inc. | Terminated |
| Class I | April 14, 2021 | Telmisartan Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic… | Labeling: Label-mixup | Alembic Pharmaceuticals Limited | Terminated |
| Class II | April 14, 2021 | Guanfacine extended-release Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by:… | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate | Apotex Corp. | Ongoing |
| Class III | April 14, 2021 | Metformin Hydrochloride Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only,… | Failed Moisture Limits: Out of specification for water content | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |