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 Baclofen injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling a specific lot of BAC/FENT/MORP injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The affected products were distributed nationwide.
Assurance Infusion is recalling specific lots of Morphine 30mg/mL injection syringes due to a lack of sterility assurance. The affected products were distributed nationwide.
Assurance Infusion is recalling BUP 20MG/SUF 1000MCG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.
Assurance Infusion is recalling specific lots of Autologous Serum 20% Eye Drops because of a lack of sterility assurance.
Assurance Infusion is recalling specific syringes of a Baclofen, Clonidine, and Morphine injection due to a lack of sterility assurance.
Assurance Infusion is recalling Hydromorphone 15mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling 20 mL syringes of BUP 30MG/FENT 750MCG/HYDROM 15MG/ML injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Sufentanil 150mcg/mL injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 3 mg/MORP 15 mg/mL Injection syringes due to a lack of sterility assurance. The recall covers specific lots distributed nationwide.
Assurance Infusion is recalling Fentanyl 5mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling BUP 30MG/HYDROM 10MG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers products distributed nationwide in the United States.
Assurance Infusion is recalling BUP 675MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Clonazepam and Fentanyl injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling 20 mL syringes of BUP 15MG/CLON 300MCG/FENT 1500MCG/ML injection due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 35MG/FENT 1.5MG/ML in 20 mL syringes due to a lack of sterility assurance. The affected lot was distributed nationwide.