CLASS II Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
BAC 160MCG/Hydrom 16MG/ML INJ in syringe Assurance Infusion recalled
Assurance Infusion is recalling BAC 160MCG/Hydrom 16MG/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
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-0666-2020
- 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
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it was distributed
Nationwide within the United States
Questions about this recall
Is BAC 160MCG/Hydrom 16MG/ML INJ in syringe Assurance Infusion (713) 533-8800 recalled?
Yes. Assurance Infusion recalled BAC 160MCG/Hydrom 16MG/ML INJ in syringe Assurance Infusion (713) 533-8800 on 20 Dec 2019. The recall is Class II and its status is Terminated. Recall number D-0666-2020.
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lot: 12112019@20 Exp. 12/20/2019
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Assurance Infusion
All 118| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bac 225MCG/ Bup 5MG/ Clon 9MCG/ Morp 3MG/ML ML Inj recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Clon 750MCG/Morp 30MG/Suf 5MCG/ML recalled by Assurance Infusion | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Hydromorphone 5MG/ML INJ in syringe Assurance Infusion recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Testosterone CYP 200MG/ML OIL INJ recalled by Assurance Infusion | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Hydromorphone 3MG/ML INJ in syringe Assurance Infusion recalled | Assurance Infusion | Sterility | Nationwide |