CLASS II Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report

BUP 9MG/ Hydrom 25MG/ SUF 110MCG/ML INJ recalled by Assurance Infusion

Assurance Infusion is recalling BUP 9MG/ Hydrom 25MG/ SUF 110MCG/ML INJ in syringe Assurance Infusion (713) 533-8800, distributed nationwide in the US. The recall was initiated on 20 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 12172019@13 Exp. 12/26/2019

Quantity recalled1 syringe

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0719-2020
FDA event ID: 84546
Recalling firm: Assurance Infusion, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 20 Dec 2019
FDA classified: 13 Jan 2020
Reported: 22 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

20 Dec 2019	Recall initiated by company
13 Jan 2020	Classified by FDA	+24 days
22 Jan 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of sterility assurance.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Lack of sterility assurance.

Which lots are affected?

Lots: 12172019@13 Exp. 12/26/2019

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 84546

This product is part of a recall event; the main page for the event is Lipo B 25MG/50MG/50MG/1000MCG/ML Vial) in syringe recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jan 2020	CLASS II	Lipo B 25MG/50MG/50MG/1000MCG/ML Vial) in syringe recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BAC 160MCG/Hydrom 16MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 10MG/ FENT 1000MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydromorphone 2MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydrom 1MG/Morp 20MG/Suf 100MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bac 2400MCG/ Fent 2600MCG/ Morp 3600MCG/ML Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 5.3MG/ FENT 1050 MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 20MG/Clon 250MCG/Fent 7200MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 5MG/Hydrom 5MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 35MG/MORP 10MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 10MG/Hydrom 15MG/SUF 200MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	HCG 3000U/ INJ in vial Assurance Infusion (713)533 recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 21MG/Clon 252MCG/Morp 20MG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Fentanyl 1000MCG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Testosterone CYP 200MG/ML OIL in vial Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 1MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Quadmix Forte 30MG/4MG/40MCG/400MCG/ML Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydrom 17MG/Prialt 5MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bac 800MCG/Bup 6.7MG/Clon 600 Mcg/Fent 850MCG/Morp 20MG Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Baclofen 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bac 250MCG/ /Fent 3500MCG/ /Morp 25MG/ML Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Trimix Forte 4 (UA) 30MG/3MG/30MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydromorphone 1MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Ipamorelin 2000MCG/ML INJ in vial Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 20MG/SUF 105MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Trimix -A (UA) 30MG/1MG/5 MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BAC 200MCG/BUP22MG/CLON210MCG/Hydrom 15MG/SUF800MCG/ML INJ recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 30MG/ FENT 400MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 5MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 5MG/MORP 10MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Phenol 2.5% Sterile Solution in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 30MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 2.5MG/ Cloni 5MCG/ Fent 200MCG/ Suf 50MCG/ML Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 17MG/MORP 22MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 23MG/Hydrom 25MG/SUF 100MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydromorphone 4MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Clon 100MCG/Morp 12MG/ML Inj in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 15MG/Clon 400MCG/ Fent 6000MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 20MG/SUF 1000MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 20MG/Clon 300MCG/Fent 2000MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bi-Mix 30 mg/1 mg/mL Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 2MG/ Hydrom 2MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Clon 500MCG/Hydrom 5MG/ML Inj in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 3.5MG/ Hydrom 4MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Autologous Serum 20% Eye Drops recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Clon 300MCG/Morp 10MG/ML Inj in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Fentanyl 100MCG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 6MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Trimix Forte 30MG/2MG/20MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 4MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 5MG/ Hydrom 15MG/ SUF 600MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	HCG 10,000U/ INJ in vial Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	FENT 600MCG/ SUF 800MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 20MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BAC 4000MCG /FENT 600MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bac 200MCG/ Cloni 250MCG/ Morp 10MG/ML Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BAC 50MCG/ Hydrom 10MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 8MG/Clon 100MCG/Hydrom 20MG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 40MG/MORP 4MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydromorphone 15MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 5MG/MORP 20MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 30MG/Fent 750MCG/Hydrom 15MG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 4MG/FENT 3000MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 18MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 2MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Sufentanil 150MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	MORP 20MG/SUF 70MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	HCG 1,000U/ INJ in vial Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BAC 400MCG/BUP 20MG/Hydrom 15MG/SUF 1000MCG/ML INJ recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Fentanyl 3000MCG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Quadmix 30MG/2MG/20MCG/100MCG/ML INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 10MG/Hydrom 10MG/Morp 2MG/Suf 250MCG/ML Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Alprostadil 40 mcg/mL vial) Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 10MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Trimix 30MG/1MG/10MCG/ML INJ in vials Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 7MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bi-Mix Forte 30 mg/2 mg/mL Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Fentanyl 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 7MG/Hydrom 20MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Bup 15MG/Clon 600MCG/Morp 30MG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 3 mg/MORP 15 mg/mL Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydromorphone 20MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Morphine 15MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Fentanyl 5MG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydromorphone 6MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 30MG/ Hydrom 10MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BPC-157 2000 mcg/mL in vials Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 675MCG/MORP 20MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Quadmix Forte in vial Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	FENT 900MCG/SUF 210MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Hydrom 10MG/SUF 200MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 30MG/ MORP 8MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Quadmix in vial Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Fentanyl 800MCG/ML INJ in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	Clon 800MCG/Fent 2000MCG/ML Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BAC 15MCG/Hydrom 15MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020	CLASS II	BUP 40MG/FENT 3000MCG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide

More recalls from Assurance Infusion

All 118

Reported	Class	Recall	Company	Reason	Where
22 Jan 2020Drug	CLASS II	Bac 225MCG/ Bup 4.5MG/ Clon 9MCG/ Morp 3MG/ML Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Clon 750MCG/Morp 30MG/Suf 37.5MCG/ML recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Hydromorphone 5MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Testosterone CYP 200MG/ML OIL INJ recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Hydromorphone 3MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide

Other Bup recalls

All 40

Reported	Class	Recall	Company	Reason	Where
22 Jan 2020Drug	CLASS II	Bup 15MG/Clon 300MCG/ Fent 1500MCG/ML(40) Inj recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	BUP 35MG/FENT 1.5MG/ML in syringe Assurance Infusion (713) recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Bup 2.5MG/Fent 25MCG/Hydro 2MG/Morp 40MG/ML recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	BUP 3MG/Hydrom 15MG/ML INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	BUP 1MG//ML/Hydrom 7MG INJ in syringe Assurance Infusion recalled	Assurance Infusion	Sterility	Nationwide