April 2020 FDA Recall Drug by Quva Pharma, Inc.
D-1335-2020 - Presence of Particulate Matter

This Class III drug recall was voluntarily initiated by Quva Pharma, Inc. on April 23, 2020 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1335-2020

Reason for Recall
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Initiated
04-23-2020
Reported
07-01-2020
Quantity
17,050 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85547
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
QuVa Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the US.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-13-2021
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# 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