OR WAIT null SECS
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.