Safety Report: QuVa Pharma, Inc. R.E.C.K. (Ropivacain, Epinephrin, Clonidin, Ketorolac) 50 ml in Natriumchlorid- 60 ml BD-Spritze - zurückgerufen aufgrund von Partikeln, Sugar Land, TX, USA

Sugar Land, Texas, United States

Company name: QuVa Pharma, Inc.
Brand name: QuVa
Product recalled: R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe
Reason of the recall: presence of particulate matter
FDA Recall date: April 27, 2020
Recall details: 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. Listed below are the recalled lots distributed directly to hospital pharmacies between February 13, 2020 and April 21, 2020.

- Product Description: R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50ml in Sodium Chloride—60ml BD syringe.
- Product Code: 70092-1433-50.
- Lot Numbers: 30009563, 30009539, 30009489, 30009412, 30009413, 30009411, 30009410, 30009388, 30009387, 30009228, 30009227, 30009139, 30009138, 30009074, 30009073, 30008949, 30008859, 30008861, 30008554, 30008198, 30008721.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabis-recall-ketorolac-results-quva-pharmar-recall-compounded-sterile-product-reck

Source: FDA