PharMEDium Services, LLC, of Lake Forest, Illinois, has voluntarily recalled hundreds of sterile preparations compounded with a single recalled lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) to the hospital level.
The complete 81-page list of recalled products can be found on the PharMEDium website.
On April 25, Fresenius Kabi recalled the specific lot at issue after identifying particulate matter, which the company characterized as glass, during inspection of reserve samples, PharMEDium notes in a news release.
"Fresenius Kabi indicated in its recall notice that the presence of glass particulate matter in solution, if undetected and administered via the epidural route, could block drug administration, delaying therapy," PharMEDium notes. "If the particulate is able to pass through the catheter and enter the body, this could result in local inflammation, mechanical disruption of tissue or cause an immune response to the particulate."
The PharMEDium drug products affected by this recall are indicated for production of local or regional anesthesia or analgesia for surgical procedures, diagnostic and therapeutic procedures, and obstetric procedures. The products were distributed to hospital customers and acute surgery centers throughout the United States.
PharMEDium Services has hired Inmar Pharmaceutical Services to coordinate the recall. The company says Inmar will send notices via email to all affected customers, request an accounting of remaining units, quarantine the affected products, and ensure the products are destroyed.
Hospital pharmacies or acute surgery centers that have one or more of the products on the list are advised to remove the products from all points of use and quarantine in accordance with applicable hospital policy. Hospital pharmacies or acute surgery centers that may have shared these products with other hospitals should contact those hospitals that received the products.
More information about the recall can be found on the FDA website.
Hospital or healthcare providers with questions regarding this recall can contact PharMEDium Services at 847-457-2244 or firstname.lastname@example.org Monday through Friday, 8:00 am to 5:00 pm CST.
Adverse reactions or quality problems with these products may be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: PharMEDium Recalls Compounded Bupivacaine Products - Medscape - May 09, 2016.