FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Jun 2, 2015

Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1590-2015

Class II · Moderate risk Terminated Jun 2, 2015

Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1589-2015

Class II · Moderate risk Terminated Jun 2, 2015

Morphine 20 mg/ml Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1588-2015

Class II · Moderate risk Terminated Jun 2, 2015

Morphine 15 mg/ml Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1587-2015

Class II · Moderate risk Terminated Jun 2, 2015

Morphine 12.5 mg/ml Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1586-2015

Class II · Moderate risk Terminated Jun 2, 2015

Morphine 10 mg/ml Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1585-2015

Class II · Moderate risk Terminated Jun 2, 2015

Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1584-2015

Class II · Moderate risk Terminated Jun 2, 2015

Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1583-2015

Class II · Moderate risk Terminated Jun 2, 2015

Mitomycin 0.03% Ophthalmic Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1582-2015

Class II · Moderate risk Terminated Jun 2, 2015

Mitomycin 0.02% Ophthalmic Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1581-2015

Class II · Moderate risk Terminated Jun 2, 2015

MIC-PLUS Carnitine Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1580-2015

Class II · Moderate risk Terminated Jun 2, 2015

MIC-B12+B6 Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1579-2015

Class II · Moderate risk Terminated Jun 2, 2015

MIC-B COMPLEX Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1578-2015

Class II · Moderate risk Terminated Jun 2, 2015

MIC+Methylcobalamin 4000 mcg/ml Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1577-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50…

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1576-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 1

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1575-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1574-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 25

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1573-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 5

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1572-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 4

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1571-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 10

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1570-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methylcobalamin 1

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1569-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1568-2015

Class II · Moderate risk Terminated Jun 2, 2015

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1567-2015

Class II · Moderate risk Terminated Jun 2, 2015

Mannitol 5% Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1566-2015