FDA (Drugs) recall action 84546
The FDA (Drugs) publishes a recall like this one as 118 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 118 pages.
Lack of sterility assurance.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Assurance Infusion is recalling HCG 1,000U/1ML injection vials nationwide due to a lack of sterility assurance. Consumers should stop using the product and contact their healthcare provider.
Assurance Infusion is recalling 2 syringes of BUP 5MG/HYDROM 15MG/SUF 600MCG/ML injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Testosterone Cypionate 200mg/mL injections due to a lack of sterility assurance. The affected products were distributed nationwide.
Assurance Infusion is recalling specific lots of Baclofen and Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of TRIMIX injection due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling specific lots of Buprenorphine and Morphine injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of multi-drug syringes because they may lack sterility assurance. Patients should contact their healthcare provider for guidance.
Assurance Infusion is recalling specific lots of Hydromorphone 5mg/mL injections because they may lack sterility assurance.
Assurance Infusion is recalling BUP 20MG/SUF 105MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall is nationwide.
Assurance Infusion is recalling specific lots of Hydromorphone 2mg/mL injection syringes because of a lack of sterility assurance.
Assurance Infusion is recalling BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringes due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Ipamorelin 2000mcg/mL injections because they may lack sterility assurance.
Assurance Infusion is recalling specific lots of BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringes due to a lack of sterility assurance.
Assurance Infusion is recalling 134 vials of Quadmix Forte injection nationwide because the product lacks sterility assurance.
Assurance Infusion is recalling 10 vials of Trimix-A injection due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling Hydrom 10mg/Suf 200mcg/mL injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling two syringes of Phenol 2.5% Sterile Solution because of a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Morphine 2mg/mL injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling a specific lot of multi-drug injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling Alprostadil 40 mcg/mL injection vials nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling 20 mL syringes of BUP 15MG/CLON 600MCG/MORP 30MG/ML injection due to a lack of sterility assurance.
Assurance Infusion is recalling Fentanyl 2000mcg/mL injection syringes because of a lack of sterility assurance. The recall covers products distributed nationwide.
Assurance Infusion is recalling specific lots of Baclofen and Fentanyl Injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling 358 vials of Trimix Forte injection nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling 166 vials of Testosterone Cypionate 200mg/mL oil injection due to a lack of sterility assurance. The product was distributed nationwide.