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 specific lots of Testosterone Cypionate 200mg/mL oil due to a lack of sterility assurance. The affected vials were distributed nationwide.
Assurance Infusion is recalling specific lots of Buprenorphine and Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling Hydromorphone 1mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling Fentanyl 1000mcg/mL injection syringes nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Morphine 18mg/mL injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of Buprenorphine and Morphine injection due to a lack of sterility assurance. The affected product was distributed nationwide.
Assurance Infusion is recalling specific lots of Morphine 20mg/mL injection syringes nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 5MG/MORP 10MG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers lots 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 Morphine 1mg/mL injection syringes due to a lack of sterility assurance. The affected products were distributed nationwide.
Assurance Infusion is recalling Hydromorphone 4mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling a specific lot of Clonidine and Morphine injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling BUP 17MG/MORP 22MG/ML injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling LIPO B 25MG/50MG/50MG/1000MCG/ML products due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling a specific lot of BUP 20MG/CLON 300MCG/FENT 2000MCG/ML Injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific syringes of Baclofen, Fentanyl, and Morphine injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Buprenorphine and Morphine injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Hydromorphone 6mg/mL injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of HCG 10,000U/1ML injections due to a lack of sterility assurance. The affected products were distributed nationwide.
Assurance Infusion is recalling Hydrom and Prialt injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling 190 vials of Quadmix injection nationwide due to a lack of sterility assurance. The recall covers nine specific lots distributed across the United States.
Assurance Infusion is recalling specific lots of Sufentanil 300mcg/mL injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling Buprenorphine and Hydromorphone Injection in 20 mL syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling 1,290 vials of TRIMIX injection nationwide due to a lack of sterility assurance. No specific illnesses or injuries are reported in the source text.
Assurance Infusion is recalling specific lots of Sufentanil 55.5 mcg/mL injection syringes due to a lack of sterility assurance.