PharmMEDium Services LLC, is recalling several lots of drug products including injections of the opioids fentanyl, morphine and hydromorphine, because the sterility of the products cannot be ensured. Use of a drug intended to be sterile that is not sterile could cause serious infections that could be life threatening. The recall affects all products currently within their labeled expiration date. To date, PharmMEDium has not received any reports or complaints related to this issue.
The recall comes following a Food and Drug Administration (FDA) inspection at the company’s Memphis laboratory, after which the agency requested verification of acceptable microbiological testing results of the ISO5 environment, personnel glove sampling results, media fill results, sterility testing results, and endotoxin results. The review indicated that 55 lots of different products impacting more than 25,000 units had two unsuccessful media fills that raised questions of sterility.
The remaining lots were associated with environmental monitoring or personnel monitoring excursions in the ISO5 space on hood/surface and glove tip, the company said in a press release. And while finished product release testing for both sterility and endotoxin were acceptable and no defects were identified in these products, “as a conservative measure, a recall is being initiated.”
The recall involves numerous products including opioid painkillers, anesthetics, and sedatives. A full list of recalled drug products with service codes and lot numbers can be found here.
PharMEDium is notifying its customers of the voluntary recall and instructing them to quarantine the products, discontinue use and destroy per their hospital protocol. Patients and health care providers should report any adverse events to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
The recall comes just four months after the company issued a recall of some of its compounded oxytocin products after laboratory testing found the products to contain lower potency than expected. The recall was initiated after the company received four complaints related to this issue. Oxytocin is used to start or strengthen labor contractions during childbirth and to control bleeding after childbirth.
FDA Recall Notice