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

FDA enforcement event 84546 · Class II · initiated 20 Dec 2019 · status Terminated · terminated 27 Oct 2021

DrugVoluntary: Firm initiated118 product recordsHouston, TX

Assurance Infusion (Houston, TX) initiated this drug recall on 20 Dec 2019; FDA lists 118 product records under event 84546, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 27 Oct 2021. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Assurance Infusion.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Assurance Infusion, Houston, TX.

Reason for recall

"Lack of sterility assurance."

Distribution

"Nationwide within the United States"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0662-2020	Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800	60 vials	Class II	Terminated	22 Jan 2020
D-0663-2020	Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800	32 droppers	Class II	Terminated	22 Jan 2020
D-0664-2020	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	1 syringe	Class II	Terminated	22 Jan 2020
D-0665-2020	BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0666-2020	BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0667-2020	BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0668-2020	BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0669-2020	BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0670-2020	BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0671-2020	BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0672-2020	BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0673-2020	BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0674-2020	BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0675-2020	BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0676-2020	BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800	2 syringes	Class II	Terminated	22 Jan 2020
D-0677-2020	Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800	15 vials	Class II	Terminated	22 Jan 2020
D-0678-2020	Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800	5 vials	Class II	Terminated	22 Jan 2020
D-0679-2020	BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800	28 vials	Class II	Terminated	22 Jan 2020
D-0680-2020	BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0681-2020	BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0682-2020	BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0683-2020	BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800	2 syringes	Class II	Terminated	22 Jan 2020
D-0684-2020	BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0685-2020	BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800	2 syringes	Class II	Terminated	22 Jan 2020
D-0686-2020	BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0687-2020	BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0688-2020	BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0689-2020	BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800	2 syringe	Class II	Terminated	22 Jan 2020
D-0690-2020	BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0691-2020	BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0692-2020	BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0693-2020	BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0694-2020	BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0695-2020	BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0696-2020	BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0697-2020	BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0698-2020	BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0699-2020	BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0700-2020	BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0701-2020	BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0702-2020	BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800	2 syringes	Class II	Terminated	22 Jan 2020
D-0703-2020	BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0704-2020	BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0705-2020	BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0706-2020	BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0707-2020	BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0708-2020	BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0709-2020	BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0710-2020	BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0711-2020	BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0712-2020	BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800	2 syringes	Class II	Terminated	22 Jan 2020
D-0713-2020	BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0714-2020	BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0715-2020	BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0716-2020	BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0717-2020	BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0718-2020	BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0719-2020	BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020
D-0720-2020	CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800	19 vials	Class II	Terminated	22 Jan 2020
D-0721-2020	CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800	1 syringe	Class II	Terminated	22 Jan 2020

Showing 60 of 118 product records; the FDA enforcement report lists all of them.

Context

68%of 2019 drug events are Class II362 events that year

118product records in this event

1event on this register for the firm

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of sterility assurance."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide within the United States"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Oct 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.