PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 1, 2020 Initiated: April 23, 2020 #D-1335-2020

Product Description

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

Details

Recalling Firm
QuVa Pharma, Inc.
Units Affected
17,050 syringes
Distribution
Distributed Nationwide in the US.
Location
Sugar Land, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by QuVa Pharma, Inc.. Units affected: 17,050 syringes.
Why was this product recalled?
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Which agency issued this recall?
This recall was issued by the FDA Drug on July 1, 2020. Severity: Low. Recall number: D-1335-2020.