Premier Pharmacy Labs Recalls Products Due to Sterility Concerns

Premier Pharmacy Labs announced on April 11, 2018 that it was voluntarily recalling products because of a potential lack of sterility assurance. The recall was initiated after the company detected microbial contamination during routine testing of subsequent unreleased product lots. An interaction between the product syringe and tamper-evident container closure was found. The company stated in a press release that this interaction may result in the potential introduction of microorganisms.

While the company has not yet received any complaints about adverse events, it warns that use 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.” 

Products affected by the recall, which were distributed nationwide to hospital pharmacies, clinics, and healthcare facilities, include the following:

• 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.

More product information, including lot numbers and beyond use dates, can be found on FDA’s website.

Source: FDA