Premier Pharmacy Labs is recalling several lots of the injectable opioids morphine and hydromorphone and the injectable anesthesia reversal agent neostigmine methylsulfate, because the sterility of the drug products is in question.
The possibility of 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 microorganisms being introduced into the products.
Administering of non-sterile injections that are intended to be sterile may result in a site-specific or systemic infection, which may cause hospitalization, significant morbidity (permanent organ damage), or fatal outcome. To date, Premier Pharmacy Labs has not received any reports of adverse events related to this recall.
A list of recalled products with their Product NDC Numbers, Lot Numbers, Beyond Use Dates and Distribution Dates can be found on the company’s press release. About 14,000 syringes are involved in this recall.
Premier Pharmacy Labs is notifying its distributors and customers of this recall and arranging for the return or replacement of all affected products. Any adverse events related to products involved in this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice