Drug Recalls

Assurance Infusion

Class II Terminated

HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0742-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0708-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0765-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0681-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0687-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0735-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0769-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0697-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0662-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0678-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0724-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800

Reason: Lack of sterility assurance.

D-0736-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0713-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0696-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0695-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0680-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0773-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0683-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0721-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0756-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0776-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0728-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0689-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800

Reason: Lack of sterility assurance.

D-0664-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0775-2020 January 22, 2020 Houston, TX

FDA Enforcement Report