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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.

Strides Pharma

Class I - Dangerous

Failed Dissolution Specifications

Sep 27, 2021 Prescription Drugs Nationwide View Details →

ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

Alpha-Tek

Class I - Dangerous

Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

Jul 16, 2021 Other Drugs Nationwide View Details →

Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.

Azurity Pharmaceuticals

Class I - Dangerous

Product Mix-up: Incorrect diluent component included in the kit.

Aug 24, 2021 Prescription Drugs Nationwide View Details →

Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11

Akorn

Class I - Dangerous

Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.

Oct 4, 2021 Prescription Drugs Nationwide View Details →

Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.

AMIVAS (US)

Class I - Dangerous

Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.

Sep 27, 2021 Prescription Drugs Nationwide View Details →

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

RISING PHARMACEUTICALS

Class I - Dangerous

Labeling: Incorrect Instructions

Sep 2, 2021 Prescription Drugs View Details →

ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1

IntegraDose Compounding Services

Class I - Dangerous

Lack of sterility assurance.

Sep 17, 2021 Prescription Drugs View Details →

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

Washington Homeopathic Products

Class I - Dangerous

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Over-the-Counter Nationwide View Details →

Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2

Johnson & Johnson Consumer

Class I - Dangerous

cGMP Deviations

Jul 14, 2021 Other Drugs Nationwide View Details →

Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed by JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858

Johnson & Johnson Consumer

Class I - Dangerous

cGMP Deviations

Jul 14, 2021 Other Drugs Nationwide View Details →

Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213

New Vitalis Pharmacy LLC

Class I - Dangerous

Lack of Assurance of Sterility

Sep 22, 2021 Prescription Drugs Nationwide View Details →

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.

Washington Homeopathic Products

Class I - Dangerous

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Other Drugs Nationwide View Details →

Neutrogena 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

Johnson & Johnson Consumer

Class I - Dangerous

cGMP Deviations

Jul 14, 2021 Other Drugs Nationwide View Details →

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6

Johnson & Johnson Consumer

Class I - Dangerous

cGMP Deviations

Jul 14, 2021 Other Drugs Nationwide View Details →

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.

Washington Homeopathic Products

Class I - Dangerous

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Prescription Drugs Nationwide View Details →

Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2

Johnson & Johnson Consumer

Class I - Dangerous

cGMP Deviations

Jul 14, 2021 Other Drugs Nationwide View Details →

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.

Washington Homeopathic Products

Class I - Dangerous

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Prescription Drugs Nationwide View Details →

Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, WHP Homeopathic Medicine, Washington Hoemopathis Producs, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

Washington Homeopathic Products

Class I - Dangerous

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Other Drugs Nationwide View Details →

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.

Washington Homeopathic Products

Class I - Dangerous

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

Aug 20, 2021 Other Drugs Nationwide View Details →

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4

Johnson & Johnson Consumer

Class I - Dangerous

cGMP Deviations

Jul 14, 2021 Other Drugs Nationwide View Details →