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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4681–4700 of 17,755 recalls

Class IITerminated

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.

Washington Homeopathic Products, Inc.

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

August 20, 2021 · DrugView details →

Class IITerminated

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.

Washington Homeopathic Products, Inc.

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

August 20, 2021 · DrugView details →

Class IITerminated

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,

Washington Homeopathic Products, Inc.

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

August 20, 2021 · DrugView details →

Class IITerminated

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

Eli Lilly & Company

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.

August 19, 2021 · DrugView details →

Class IITerminated

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

Rhodes Pharmaceuticals, L.P.

Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle

August 19, 2021 · DrugView details →

Class IITerminated

Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy

Prescription Labs Inc dba Greenpark

Lack of Assurance of Sterility

August 18, 2021 · DrugView details →

Class ICompleted

X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

Phe Inc

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

August 18, 2021 · DrugView details →

Class IITerminated

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

RemedyRepack Inc.

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

August 17, 2021 · DrugView details →

Class IITerminated

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IIOngoing

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.

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

August 13, 2021 · DrugView details →

Class IITerminated

ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

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