Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIQuebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IICistus 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIAlthaea 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIAlthaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIAlthaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIAlthaea 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIKali 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IILa 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% Chelidoni
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIViola 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIVerbena 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIQuebracho 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIHumulus 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IICistus 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IICinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIAlthaea 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IICedar 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIHaloderm 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIYeast 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIOccular 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.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZTE-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 Sprin
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIAconitum 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.
- 2021-10-06FDA-DrugFresenius Kabi USA LLCClass IIMorphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
Defective container: Cracked vials leading to lack of sterility assurance
- 2021-10-06FDA-DrugMonarch PCM, LLCClass IIHydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01
Finished product specification did not meet USP specifications.
- 2021-10-06FDA-DrugAmerican Health PackagingClass IIValproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- 2021-10-06FDA-DrugNew Vision Pharmaceuticals LLCClass IIICVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895
Subpotent Drug
- 2021-10-06FDA-DrugNew Vision Pharmaceuticals LLCClass IIIDaytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Subpotent Drug
- 2021-10-06FDA-DrugViatrisClass IILyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
Failed Dissolution Specifications
- 2021-10-06FDA-DrugJohnson & Johnson Consumer, Inc.Class IINeutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6
cGMP Deviations
- 2021-10-06FDA-DrugJohnson & Johnson Consumer, Inc.Class IINeutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9
cGMP Deviations
- 2021-10-06FDA-DrugJohnson & Johnson Consumer, Inc.Class IINeutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5
cGMP Deviations
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