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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 8081–8100 of 17,773 recalls

Class IIITerminated

Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ

Amerigen Pharmaceuticals Inc.

Failed Dissolution Specifications

December 20, 2018 · DrugView details →

Class IITerminated

Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454

Teva Pharmaceuticals USA

Failed dissolution specifications

December 19, 2018 · DrugView details →

Class IITerminated

Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875

Roberts Home Medical LLC

CGMP Deviations

December 19, 2018 · DrugView details →

Class IITerminated

CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801

LGM Pharma LLC

CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

December 18, 2018 · DrugView details →

Class IITerminated

Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00

Duren Health Mart Pharmacy

Lack of Processing Controls.

December 17, 2018 · DrugView details →

Class IITerminated

Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99

Duren Health Mart Pharmacy

Lack of Processing Controls.

December 17, 2018 · DrugView details →

Class IITerminated

Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

Class IITerminated

Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

Promise Pharmacy, LLC

Lack of sterility assurance.

December 17, 2018 · DrugView details →

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