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 Hydrom 1mg/Morp 20mg/Suf 100mcg/mL injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling Bi-Mix 30 mg/1 mg/mL injections because of a lack of sterility assurance. The affected vials were distributed nationwide.
Assurance Infusion is recalling BUP 4MG/FENT 3000MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 35MG/MORP 10MG/ML Injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of HCG 3000U/1ML injections because they lack sterility assurance. The recall covers products distributed nationwide.
Assurance Infusion is recalling BUP 2MG/HYDROM 2MG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling BUP 3.5MG/HYDROM 4MG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling specific lots of Morphine 6mg/mL injection syringes due to a lack of sterility assurance. The products were distributed nationwide.
Assurance Infusion is recalling specific lots of a Clonazepam and Morphine injection because of a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of multi-drug injection syringes because of a lack of sterility assurance.
Assurance Infusion is recalling specific lots of a multi-drug injection syringe due to a lack of sterility assurance.
Assurance Infusion is recalling Morphine 15mg/mL injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide in the United States.
Assurance Infusion is recalling QUADMIX FORTE in 1 mL vials because of a lack of sterility assurance. The recall covers 5 vials distributed nationwide.
Assurance Infusion is recalling QUADMIX in 1 mL vials because of a lack of sterility assurance. The affected lot was distributed nationwide.
Assurance Infusion is recalling Fentanyl 800mcg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling BUP 1MG//ML/HYDROM 7MG Injection in 20 mL syringes due to a lack of sterility assurance. The recall covers nationwide distribution in the United States.
Assurance Infusion is recalling BUP 3MG/HYDROM 15MG/ML INJ syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling 20 vials of Trimix Forte Plus injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of Hydromorphone 3mg/mL injection syringes due to a lack of sterility assurance. The products were distributed nationwide.
Assurance Infusion is recalling BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide.
Assurance Infusion is recalling BUP 8MG/CLON 100MCG/HYDROM 20MG/ML Injection syringes due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 5.3MG/FENT 1050 MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of BUP 20MG/CLON 250MCG/FENT 7200MCG/ML Injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Buprenorphine and Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ syringes due to a lack of sterility assurance.