FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Jun 2, 2015

Lipotropic

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

The Compounding Pharmacy of America D-1690-2015

Class II · Moderate risk Terminated Jun 2, 2015

Lipo-Vite III

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

The Compounding Pharmacy of America D-1689-2015

Class II · Moderate risk Terminated Jun 2, 2015

LIPO-VITE Injection

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

The Compounding Pharmacy of America D-1688-2015

Class II · Moderate risk Terminated Jun 2, 2015

LIPO-Tropic Injectable

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

The Compounding Pharmacy of America D-1687-2015

Class II · Moderate risk Terminated Jun 2, 2015

LIPO-EXTREME Injectable

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

The Compounding Pharmacy of America D-1686-2015

Class II · Moderate risk Terminated Jun 2, 2015

LIPO-DEN MODIFIED Injection

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

The Compounding Pharmacy of America D-1685-2015

Class II · Moderate risk Terminated Jun 2, 2015

Lipo-DEN III Injection

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

The Compounding Pharmacy of America D-1684-2015

Class II · Moderate risk Terminated Jun 2, 2015

Lipo-B MMC I

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

The Compounding Pharmacy of America D-1683-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1

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

The Compounding Pharmacy of America D-1682-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 70 mg/ml +Fentanyl 16

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

The Compounding Pharmacy of America D-1681-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125…

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

The Compounding Pharmacy of America D-1680-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 60 mg/ml + Fentanyl 7

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

The Compounding Pharmacy of America D-1679-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 60 mg/ml + Fentanyl 15

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

The Compounding Pharmacy of America D-1678-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 60 mg/ml + Fentanyl 20

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

The Compounding Pharmacy of America D-1677-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 60 mg/ml + Fentanyl 1

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

The Compounding Pharmacy of America D-1676-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 50 mg/ml + Fentanyl 3

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

The Compounding Pharmacy of America D-1675-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 45 mg/ml + Fentanyl 10

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

The Compounding Pharmacy of America D-1674-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution

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

The Compounding Pharmacy of America D-1673-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1

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

The Compounding Pharmacy of America D-1672-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 3 mg/ml + Baclofen 2

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

The Compounding Pharmacy of America D-1671-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromorphone 20 mg/ml + Clonidine 1

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

The Compounding Pharmacy of America D-1670-2015

Class II · Moderate risk Terminated Jun 2, 2015

Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120…

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

The Compounding Pharmacy of America D-1669-2015

Class II · Moderate risk Terminated Jun 2, 2015

Calmme Injectable

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

The Compounding Pharmacy of America D-1668-2015

Class II · Moderate risk Terminated Jun 2, 2015

Buckshot Injectable

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

The Compounding Pharmacy of America D-1667-2015

Class II · Moderate risk Terminated Jun 2, 2015

Bi-Mix Medium

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

The Compounding Pharmacy of America D-1666-2015