FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated May 17, 2016

Itraconazole 0.2%/Mupirocin 0.2%/Triamcinolone 0.03% Nasal Spray

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

Well Care Compounding Pharmacy D-1028-2016

Class II · Moderate risk Terminated May 17, 2016

Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray

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

Well Care Compounding Pharmacy D-1027-2016

Class II · Moderate risk Terminated May 17, 2016

Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic Solution

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

Well Care Compounding Pharmacy D-1026-2016

Class II · Moderate risk Terminated May 17, 2016

Quad-Mix #3

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

Well Care Compounding Pharmacy D-1025-2016

Class II · Moderate risk Terminated May 17, 2016

Vitamin B Complex # 3

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

Well Care Compounding Pharmacy D-1024-2016

Class II · Moderate risk Terminated May 17, 2016

Vitamin B Complex # 1

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

Well Care Compounding Pharmacy D-1023-2016

Class II · Moderate risk Terminated May 17, 2016

Vancomycin 50mg/Ml Ophth Solution

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

Well Care Compounding Pharmacy D-1022-2016

Class II · Moderate risk Terminated May 17, 2016

Tri-Mix # 6

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

Well Care Compounding Pharmacy D-1021-2016

Class II · Moderate risk Terminated May 17, 2016

Tri-Mix # 5

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

Well Care Compounding Pharmacy D-1020-2016

Class II · Moderate risk Terminated May 17, 2016

Tri-Mix # 4

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

Well Care Compounding Pharmacy D-1019-2016

Class II · Moderate risk Terminated May 17, 2016

Tri-Mix # 3

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

Well Care Compounding Pharmacy D-1018-2016

Class II · Moderate risk Terminated May 17, 2016

Tri-Mix # 2

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

Well Care Compounding Pharmacy D-1017-2016

Class II · Moderate risk Terminated May 17, 2016

Tri-Mix # 1

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

Well Care Compounding Pharmacy D-1016-2016

Class II · Moderate risk Terminated May 17, 2016

Testosterone Cypionate 200mg/Ml

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

Well Care Compounding Pharmacy D-1015-2016

Class II · Moderate risk Terminated May 17, 2016

Testosterone Cypionate 175mg/Ml

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

Well Care Compounding Pharmacy D-1014-2016

Class II · Moderate risk Terminated May 17, 2016

Testosterone Cypionate 150mg/Ml

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

Well Care Compounding Pharmacy D-1013-2016

Class II · Moderate risk Terminated May 17, 2016

Testosterone Cypionate 10mg/Ml

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

Well Care Compounding Pharmacy D-1012-2016

Class II · Moderate risk Terminated May 17, 2016

Testosterone Cypionate 100mg/Ml

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

Well Care Compounding Pharmacy D-1011-2016

Class II · Moderate risk Terminated May 17, 2016

Super Tri-Mix #4

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

Well Care Compounding Pharmacy D-1010-2016

Class II · Moderate risk Terminated May 17, 2016

Super Tri-Mix #1

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

Well Care Compounding Pharmacy D-1009-2016

Class II · Moderate risk Terminated May 17, 2016

Quad-Mix #4

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

Well Care Compounding Pharmacy D-1008-2016

Class II · Moderate risk Terminated May 17, 2016

Quad-Mix #2

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

Well Care Compounding Pharmacy D-1007-2016

Class II · Moderate risk Terminated May 17, 2016

Quad-Mix #1

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

Well Care Compounding Pharmacy D-1006-2016

Class II · Moderate risk Terminated May 17, 2016

Phosphatidylcholine/Deoxycholic Acid- 5%/4.75%

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

Well Care Compounding Pharmacy D-1005-2016

Class II · Moderate risk Terminated May 17, 2016

Phenylepherine 0.5%

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

Well Care Compounding Pharmacy D-1004-2016