Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0860-2021 | 08-20-2021 | Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic Medicine, For Manufacturing Use Only. 1.957 kg Lactose, Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1.957 kg. | Class II | Terminated |
| D-0878-2021 | 08-20-2021 | Viola od 6X, 30X, Bee Stings*, Sucrose/Lactose Pills, 6X Packaged in a) 4 Dram, UPC 7 40640 50139 9; 30X Packaged in b) 4 dr, UPC 7 40640 50141 2; c) 2 oz, UPC 7 40640 50149 8; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / N/A | Class II | Terminated |
| D-0885-2021 | 08-20-2021 | ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8X, Astragalus Menziesli 8X, Carbo Vegetabilis 8X, Chamomilla 3X, Hydrastis Canadensis 3X, Echinacea Angustifolia 12X, Pulsatilla 11X, Anas Barariae, Hepatis ET 60C, Anas Barariae, Hepatis ET 100C, Anas Barariae, Hepatis ET 200C, Carduus Marianus 6X, Taraxacum Officinale 4X, Berberis Aquifolium 8X, Zingiber Officinal 8X, Allium Sativum 4X, Dilution Alcohol 20%. Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/1 Liter bottles | Class II | Terminated |
| D-0886-2021 | 08-20-2021 | ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Alfalfa 3X, Dilution Alcohol 20%, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 225411, Manufactured for Optimal Health Dimensions, Washington Homeopathic Products, Inc. 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 1/liter | Class II | Terminated |
| D-0884-2021 | 08-20-2021 | Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/1 Liter bottle | Class II | Terminated |
| D-0862-2021 | 08-20-2021 | Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder allerges, Manufactured for Peoples RX, 3801 S Lamar, Austin, TX 78704. UPC 7 40640 64166 8 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1,931 bottles | Class II | Terminated |
| D-0869-2021 | 08-20-2021 | Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged in a) 2 Dram; 10X Packaged in b) 2 Dram; 12X Packaged in c) 2 Dram; d) 4 Dram; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 12 bottles | Class II | Terminated |
| D-0863-2021 | 08-20-2021 | Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0857-2021 | 08-20-2021 | Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol HPUS: 24X, packaged in 50 mL containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0883-2021 | 08-20-2021 | Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimicifuga Racemosa 24X, Cinchona Officinalis 24X, Colocynthis 24X, Histaminum Hydrochloricum 24X, Lycopodium Clavatum 24X, Sulphur 24X, Tataxacum Officinale 24X, Veratrum Album 24X, Sepia 30X, Strontium Carbonicum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3/1 Liter bottles | Class II | Terminated |
| D-0893-2021 | 08-20-2021 | Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 10X, 15X, 24X, 30X, packaged in 2 dr containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 2 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 7X, 8X, 10X, 12X, 15X, 16X, 18X, 30X, packaged in 4 dram containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0875-2021 | 08-20-2021 | Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0879-2021 | 08-20-2021 | Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Versicolor 24X, Millefolium 24X, Rumex Crispus 24X, Selenium Metallicum 12X, Selenium Metallicum 60X, Solidago Virgaurea 12X, Solidago Virgaurea 24X, Solidago Virgaurea 60X, Spiraea Ulmaira 24X, Taraxacum Officinale 24X, Urtica Dioica 24X, Uva-Ursi 24X, Zincum Muriaticum 13X, Zincum Mruiaticum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/1 Liter bottles | Class II | Terminated |
| D-0876-2021 | 08-20-2021 | Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ml; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / N/A | Class II | Terminated |
| D-0867-2021 | 08-20-2021 | Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C Packaged as a) 4dr; 6C Packaged as b) 4 Dram UPC 7 40640 44092 6; c) 2 oz UPC 7 40640 44100 8; 12C Packaged as d) 4 Dram; e) 2 oz; 30C Packaged as f) 2 dr UPC 7 40640 44090 2; g) 4 Dram, UPC 7 40640 44094 0; h) 1 oz, UPC 7 40640 44098 8; i) 2 oz, UPC 7 40640 44102 2; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 61 bottles | Class II | Terminated |
| D-0868-2021 | 08-20-2021 | Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, WHP Homeopathic Medicine, Washington Hoemopathis Producs, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3 bottles | Class II | Terminated |
| D-0866-2021 | 08-20-2021 | Humulus 6X, 15X, Sucrose/Lactose Pills, 6X Packaged as a) 4dr, UPC 7 40640 33969 5; 15X Packaged as b) 4 dr; WHP Homeopathic Medicine. Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 bottles | Class II | Terminated |
| D-0881-2021 | 08-20-2021 | ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1 1/Liter bottle | Class II | Terminated |
| D-0895-2021 | 08-20-2021 | Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0870-2021 | 08-20-2021 | La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Clavatum 10X, 12% Carbo Vegetabilis 16X, 12% Natrum Muriaticum 9X, 12% Calcarea Carbonica 12X, 10% Hypothalamus 30X, 6% Pituitarum Posterium 12X, 6% Pituitarum Posterium 30C, 3% Natrum Phosphoricum 12X, 3% Graphites 30X, 3# Agnus Castus 6X, 3% Thiosinaminum 8X, 3% Phytolacca Decandra 12X, 3% Magnesia Phosphorica 10X, 3% Ornithogalum Umbellatum 6X, 3% Chelidonium Majus 6X, 3% Quercus Robur 14X, 3% Nux Vomica 30X, Manufactured by Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/149,980 mL bottles | Class II | Terminated |
| D-0892-2021 | 08-20-2021 | Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 oz containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 7X, 12X, packaged in 2 dr containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 12X, 20X, packaged in 2 oz containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 9X,11X, 24X, packaged in 4 dr containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 4 oz containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0894-2021 | 08-20-2021 | Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0882-2021 | 08-20-2021 | Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 1/liter bottle | Class II | Terminated |
| D-0888-2021 | 08-20-2021 | ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%, Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1 1/liter | Class II | Terminated |
| D-0859-2021 | 08-20-2021 | Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x Euphrasia Officinalis 7X Sabadilla 7X, WHP Homeopathic Medicine For Manufacturing Only, 500 ml. Manufcatured by Washington Homeopathic Products 260JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/500 mL bottles | Class II | Terminated |
| D-0858-2021 | 08-20-2021 | ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. WHP Homeopathic Medicine. For Manufacturing Use Only, Manufactured for Optimal Health Dimensi. Manufactured By: Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3/1 Liter bottles | Class II | Terminated |
| D-0872-2021 | 08-20-2021 | Althaea Officinalis 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0871-2021 | 08-20-2021 | Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Use Only. Manufactured by Washington Homeopathic Products 260JR hawvermale Way Berkeley Springs WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 12/960 mL bottles | Class II | Terminated |
| D-0865-2021 | 08-20-2021 | Cistus Canadensis 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Packaged as a) 1 OZ, UPC 7 40640 28177 2, b) 4 dr, UPC 7 40640 28173 4; 10X Packaged as c) 4 dr; 15X Packaged as d) 1 OZ; 30X Packaged as e) 2 Dram, UPC 7 40640 28171 0, f) 4 dr, UPC 7 40640 28175 8; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 17 bottles | Class II | Terminated |
| D-0861-2021 | 08-20-2021 | Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411. Marketed by: Health Specialty | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3 Liter bottles | Class II | Terminated |
| D-0773-2021 | 08-19-2021 | Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 Package NDCs: 0002-1433-01; 0002-1433-80; 0002-1433-61; 0002-1434-01; 0002-1434-80; 0002-1434-61; 0002-2236-01; 0002-2236-80; 0002-2236-61; 0002-3182-01; 0002-3182-80; 0002-3182-61 | Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product. | Eli Lilly & Company / 119,539 4-packs | Class II | Terminated |
| D-0794-2021 | 08-19-2021 | Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01 Package NDCs: 42858-001-01; 42858-001-10; 42858-002-01; 42858-002-10; 42858-003-01; 42858-004-01; 42858-005-01 | Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle | Rhodes Pharmaceuticals, L.P. / 55,344/100 count bottles | Class II | Terminated |
| D-0804-2021 | 08-18-2021 | Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy | Lack of Assurance of Sterility | Prescription Labs Inc dba Greenpark / 350 bottles | Class II | Terminated |
| D-0819-2021 | 08-18-2021 | X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2 | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. | Phe Inc / 15000 packets | Class I | Completed |
| D-0754-2021 | 08-17-2021 | Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01 | A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles. | RemedyRepack Inc. / 4 | Class II | Terminated |
| D-0033-2022 | 08-13-2021 | ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0049-2022 | 08-13-2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0051-2022 | 08-13-2021 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0050-2022 | 08-13-2021 | TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0054-2022 | 08-13-2021 | ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0030-2022 | 08-13-2021 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0066-2022 | 08-13-2021 | PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0037-2022 | 08-13-2021 | ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0063-2022 | 08-13-2021 | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0056-2022 | 08-13-2021 | CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0053-2022 | 08-13-2021 | ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0055-2022 | 08-13-2021 | BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0043-2022 | 08-13-2021 | TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0031-2022 | 08-13-2021 | ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0057-2022 | 08-13-2021 | FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0042-2022 | 08-13-2021 | TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0064-2022 | 08-13-2021 | MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0041-2022 | 08-13-2021 | PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0047-2022 | 08-13-2021 | TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0044-2022 | 08-13-2021 | TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0032-2022 | 08-13-2021 | ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0052-2022 | 08-13-2021 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0045-2022 | 08-13-2021 | TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0028-2022 | 08-13-2021 | Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0034-2022 | 08-13-2021 | CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0065-2022 | 08-13-2021 | MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0036-2022 | 08-13-2021 | DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0802-2021 | 08-13-2021 | Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701 | Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. | Akorn, Inc. / 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289 | Class II | Terminated |
| D-0067-2022 | 08-13-2021 | SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0040-2022 | 08-13-2021 | LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0029-2022 | 08-13-2021 | Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0061-2022 | 08-13-2021 | METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0059-2022 | 08-13-2021 | METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0048-2022 | 08-13-2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0058-2022 | 08-13-2021 | METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0039-2022 | 08-13-2021 | HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0035-2022 | 08-13-2021 | CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0046-2022 | 08-13-2021 | TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0062-2022 | 08-13-2021 | MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0060-2022 | 08-13-2021 | METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0038-2022 | 08-13-2021 | GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0766-2021 | 08-13-2021 | Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4 | Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing. | SigmaPharm Laboratories LLC / 1,993 bottles | Class II | Terminated |
| D-0753-2021 | 08-13-2021 | Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05 Package NDCs: 68382-092-17; 68382-092-01; 68382-092-05; 68382-093-17; 68382-093-05; 68382-093-01; 68382-094-17; 68382-094-01; 68382-094-05; 68382-095-17; 68382-095-01; 68382-095-05 | Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle | Zydus Pharmaceuticals (USA) Inc / 2880 bottles | Class II | Terminated |
| D-0809-2021 | 08-13-2021 | Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56. Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-28; 0069-0471-03; 0069-0471-28 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0811-2021 | 08-13-2021 | Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0810-2021 | 08-13-2021 | Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56. Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-28; 0069-0471-03; 0069-0471-28 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0808-2021 | 08-13-2021 | Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets. | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / | Class II | Ongoing |
| D-0755-2021 | 08-12-2021 | Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10 | Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured. | ANHUI WELCOME FOREIGN TRADE CO.,LTD. / 63,750 | Class II | Terminated |
| D-0777-2021 | 08-11-2021 | Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36 | CGMP Deviations | Granules USA, Inc. / 11,450,000 tablets | Class II | Terminated |
| D-0797-2021 | 08-11-2021 | Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108 | Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine | Ebay Seller - John Nguyen / 35 boxes | Class I | Terminated |
| D-0768-2021 | 08-10-2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 | Lack of Assurance of Sterility | SterRx, LLC / 3378 bags | Class II | Terminated |
| D-0767-2021 | 08-10-2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01 | Non-Sterility: firm's third party lab confirmed microbial contamination. | SterRx, LLC / 1098 bags | Class I | Terminated |
| D-0756-2021 | 08-06-2021 | Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01 | Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations. | XELLIA PHARMACEUTICALS USA, LLC / 9,161 vials 50 mg and 100 mg vials total | Class II | Terminated |
| D-0757-2021 | 08-06-2021 | Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01 | Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations. | XELLIA PHARMACEUTICALS USA, LLC / 9,161 (50mg and 100 mg vials total) | Class II | Terminated |
| D-0807-2021 | 08-06-2021 | Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61 | Failed Dissolution Specifications | The Harvard Drug Group / 4 Cartons of 100 count each | Class II | Terminated |
| D-0728-2021 | 08-05-2021 | Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711 | Out of specification results for conductivity. | DuPont Nutrition USA, Inc / 2,384,720 kg | Class III | Terminated |
| D-0771-2021 | 08-05-2021 | Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01 Package NDCs: 0143-9240-01; 0143-9241-01 | Labeling: Not elsewhere classified: Mislabeling | Hikma Pharmaceuticals USA Inc. / 1,152 vials | Class III | Terminated |
| D-0800-2021 | 08-03-2021 | Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50. | Superpotent Drug | Teligent Pharma, Inc. / 32,544 glass bottles | Class I | Ongoing |
| D-0289-2022 | 08-03-2021 | Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40 | Failed Impurities/Degradation Specifications | The Harvard Drug Group / 2,239 bottles | Class II | Terminated |
| D-0787-2021 | 08-02-2021 | Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-15 Package NDCs: 33342-060-07; 33342-060-15; 33342-060-12; 33342-060-10; 33342-060-44 | Presence of foreign matter | Macleods Pharma Usa Inc / 444,000 tablets / 888 unit packs of 500 count | Class II | Terminated |
| D-0631-2022 | 08-02-2021 | 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns. | Je Dois Lavoir LLC / 783 bottles | Class I | Terminated |
| D-0786-2021 | 08-02-2021 | Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35 | Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group. | Akorn, Inc. / 142,188 tubes | Class II | Terminated |
| D-0765-2021 | 07-30-2021 | FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01 | Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. | Custopharm, Inc. / 19,384 vials | Class II | Terminated |
| D-0724-2021 | 07-30-2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 Package NDCs: 68968-0514-8; 68968-0525-8; 68968-0514-2 | Failed Stability Specifications; out of specification for shear. | Noven Pharmaceuticals Inc / 223,382 boxes | Class II | Ongoing |
| D-0725-2021 | 07-30-2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 Package NDCs: 68968-0514-8; 68968-0525-8; 68968-0525-2 | Failed Stability Specifications; out of specification for shear. | Noven Pharmaceuticals Inc / 70,638 boxes | Class II | Ongoing |
