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 Fentanyl and Sufentanil Injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling BPC-157 vials nationwide because the product lacks 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 Hydromorphone 20mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of Baclofen and Hydromorphone injection due to a lack of sterility assurance. The affected product was distributed nationwide.
Assurance Infusion is recalling Fentanyl 100mcg/mL injection syringes nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling 19 vials of CJC-1295 and Ipamorelin injections nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling 45 vials of Trimix Super injection nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling Fentanyl 3000mcg/mL injection syringes due to a lack of sterility assurance. The affected lots were 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 syringes containing a combination of drugs due to a lack of sterility assurance.
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 lots of Morphine 5mg/mL injection syringes due to 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 specific lots of Morphine 10mg/mL injection syringes nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling Morphine Sulfate Injection in 20 mL syringes 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 a specific lot of buprenorphine and fentanyl injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling Morphine 4mg/mL Injection in 20mL syringes due to lack of sterility assurance. The recall affects specific lots distributed nationwide.
Assurance Infusion is recalling Fentanyl and Sufentanil Injection in 20 mL syringes due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Trimix Forte 4 injection because the product may lack sterility assurance.
Assurance Infusion is recalling specific lots of Buprenorphine and Fentanyl injection due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 23MG/HYDROM 25MG/SUF 100MCG/ML Injection syringes due to a lack of sterility assurance. The recall covers nationwide distribution.
Assurance Infusion is recalling specific lots of Clonidine and Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of BUP 10MG/HYDROM 15MG/SUF 200MCG/ML Injection syringes due to a lack of sterility assurance.