R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350

FDA recall notice · announced July 1, 2020 · Quva Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350

Reason for recall

Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac

Notes

Distribution: Distributed Nationwide in the US.
Lot/code information: Lots: 30008721, Exp. 4/26/2020; 30008198, 30008554, Exp. 4/29/2020; 30008861, Exp. 4/30/2020; 30008859, Exp. 5/5/2020; 30008949, Exp. 5/10/2020; 30009073, Exp. 5/14/2020; 30009074, Exp. 30009138, Exp. 5/17/2020; 30009139, 30009227, Exp. 5/19/2020; 30009228, Exp. 5/20/2020; 30009387, 30009388, Exp. 5/27/2020; 30009410, 30009411, Exp. 5/28/2020; 30009413, Exp. 5/31/2020; 30009412, 30009489, Exp. 6/1/2020; 30009539, 30009563, Exp. 6/3/2020
Quantity: 17,050 syringes
Status: Terminated
Products in this recall event:
- R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350 (D-1335-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.