We’ve compiled a list of notable recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:
We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:
Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma Recall of Compounded Sterile Product Due to Presence of Particulate Matter
QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi.
Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials.
QuVa has reached out to all hospital pharmacy customers who purchased product from the lots affected and has asked them to: quarantine anything that is in stock to prevent use in direct patient care; complete a return response form to capture the amount of unused product; and return the finished goods to QuVa for destruction.
Read the recall statement.
CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets
CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020).
Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.
CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard infusion pump system and to remove all existing products from the U.S. market.
Read the recall update.