Assurance Infusion Recalls BAC/FENT/MORP Injection Due to Sterility Concerns
Assurance Infusion is recalling a specific lot of BAC/FENT/MORP injection due to a lack of sterility assurance. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Under the rubric, an FDA Class II recall involving a significant hazard like lack of sterility assurance in an injectable drug is classified as Severe (Score 4), particularly given the potential for serious injury from non-sterile injections.
Plain-English summary
Assurance Infusion is recalling one syringe of BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe. The recall is being conducted because of a lack of sterility assurance. The affected product is identified by Lot 12172019@6 with an expiration date of 12/26/2019.
The recalled product was distributed nationwide within the United States. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Healthcare providers and consumers should stop using the affected product and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 12172019@6 Exp. 12/26/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 118 products in this recall →Related recalls
Same manufacturer · Assurance Infusion
See all →- SevereAssurance Infusion Recalls Buprenorphine and Hydromorphone Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Hydromorphone Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Morphine Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Buprenorphine and Morphine Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighMorphine Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- SevereInfliximab Infusion Bags Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-08-21
- HighMIC/B12 Injectable Vials Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- SevereFDA Recalls Tri-MIX Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-10-14
- SevereFerric Carboxymaltose Infusion Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-08-21
- HighFentanyl Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11