D-1335-2020 Class III Terminated
FDA drug recall D-1335-2020 was initiated by QuVa Pharma, Inc. on April 23, 2020 and is designated Class III. Reason for recall: Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac The recall status is terminated (terminated January 13, 2021). Affected quantity: 17,050 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- April 23, 2020
- Termination Date
- January 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,050 syringes
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
Distribution Pattern
Distributed Nationwide in the US.
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