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 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 specific lots of Hydromorphone 3mg/mL injection syringes due to a lack of sterility assurance. The 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 specific lots of a multi-drug injection syringe due to a lack of sterility assurance.
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 two syringes of Phenol 2.5% Sterile Solution because of a lack of sterility assurance.
Assurance Infusion is recalling specific syringes containing a combination of drugs 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.
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 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 specific lots of Buprenorphine and Fentanyl injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Morphine 7mg/mL injection syringes 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 product was distributed nationwide.
Assurance Infusion is recalling Bi-Mix Forte 30 mg/2 mg/mL injections because of a lack of sterility assurance. The affected lot was distributed nationwide.
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 20 mL syringes of BUP 30MG/FENT 750MCG/HYDROM 15MG/ML injection due to a lack of sterility assurance.
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 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 Hydromorphone 4mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
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 BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringes 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 Sufentanil 300mcg/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.