FDA (Drugs) recall action 79803
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
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.
Premier Pharmacy Labs is recalling 3,570 hydromorphone syringes because routine testing of other lots found microbial contamination risks.
Premier Pharmacy Labs Inc is recalling 4,192 syringes of Morphine Sulfate 4 mg/mL PF Injection due to a lack of assurance of sterility.
Premier Pharmacy Labs is recalling NeoStigmine Methylsulfate syringes because routine testing of other lots detected microbial contamination risks.
Premier Pharmacy Labs is recalling specific lots of Morphine Sulfate Injection because routine testing of other lots detected microbial contamination risks.