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PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.
PharMEDium Services, LLC announced on Dec. 27, 2017 that it was voluntarily recalling certain lots of product because of a lack of sterility assurance. The recall was issued after an FDA inspection of the company’s Memphis location led to the agency requesting the company perform a review of all commercially distributed product compounded at the Memphis location to verify microbiological testing and sterility testing results.
According to a press release, “the review indicated that a total of 55 lots of different products impacting 25,327 units had two unsuccessful media fills. The remaining lots were associated with environmental monitoring or personnel monitoring excursions in the ISO 5 space on hood/surface and glove tip. Finished product release testing for both sterility and endotoxin were acceptable. Although there were no defects identified in these products, as a conservative measure, a recall is being initiated.”
The recalled lots included 2 mcg/mL Fentanyl Citrate and 0.2% Ropivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 1 mg/mL Morphine Sulfate in 0.9% Sodium Chloride; and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride. A complete list of recalled products can be found on FDA’s website.
As of December 27, the company has not received any reports of adverse events related to the recall. Adverse events may be reported to FDA through its MedWatch Adverse Event Reporting Program.