Premier Pharmacy Labs is voluntarily recalling the following products due to a potential lack of sterility assurance:
- Morphine Sulfate (Single Dose Syringe) 2mg/mL Preservative Free Injection
- Morphine Sulfate (Single Dose Syringe) 4mg/mL Preservative Free Injection
- Hydromorphone HCL (Single Dose Syringe) 1mg/mL Preservative Free Injection
- Neostigmine Methylsulfate (Single Dose Syringe) 1mg/mL Injection
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.
Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or a fatal outcome. To date, Premier Pharmacy Labs has not received any reports of adverse events related to this issue, but understanding the potential risk, is voluntarily initiating this product recall.
For more information, see the U.S. Food and Drug Administration’s annoucement.
(Source: The U.S. Food and Drug Administration)
