Recalls / Class III
Class IIID-1335-2020
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
- Affected lot / code info
- 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
Why it was recalled
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Recalling firm
- Firm
- QuVa Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr Ste 100, N/A, Sugar Land, Texas 77478-2576
Distribution
- Quantity
- 17,050 syringes
- Distribution pattern
- Distributed Nationwide in the US.
Timeline
- Recall initiated
- 2020-04-23
- FDA classified
- 2020-06-23
- Posted by FDA
- 2020-07-01
- Terminated
- 2021-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1335-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.