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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 8041–8060 of 17,773 recalls

Class IITerminated

Cyclosporin liquid 0.2%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Class IITerminated

Cyclosporin liquid 0.05%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Terminated

Vitamin B12 liquid 1000mcg/ml, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Class IITerminated

Glutathione liquid, 100mg/ml

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Class IITerminated

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.

PharMEDium Services, LLC.

Subpotent

January 2, 2019 · DrugView details →

Class IITerminated

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

Baxter Healthcare Corporation

Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

January 2, 2019 · DrugView details →

Class IITerminated

Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Class IITerminated

Epinephrine liquid 1:1000, RX, glass vial

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Class IITerminated

Cyclosporin liquid 1%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Class IITerminated

Cyclosporin liquid 0.5%, Rx, plastic dropper bottle

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Lack of sterility assurance.

January 2, 2019 · DrugView details →

Class IIOngoing

Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.

Aurobindo Pharma USA Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

December 31, 2018 · DrugView details →

Class IIOngoing

Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.

Aurobindo Pharma USA Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

December 31, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30

Aurobindo Pharma USA Inc.

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

December 31, 2018 · DrugView details →

Class IIOngoing

Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30

Aurobindo Pharma USA Inc.

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

December 31, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90

Aurobindo Pharma USA Inc.

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

December 31, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.

Aurobindo Pharma USA Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

December 31, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.

Aurobindo Pharma USA Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

December 31, 2018 · DrugView details →

Class IIOngoing

Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.

Aurobindo Pharma USA Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

December 31, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.

Aurobindo Pharma USA Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

December 31, 2018 · DrugView details →

Class IIOngoing

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.

Aurobindo Pharma USA Inc.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

December 31, 2018 · DrugView details →

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