Why it was recalled
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Distributed Nationwide in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1335-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 23, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- 17,050 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-1335-2020, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 85547
- Address
- 1075 W Park One Dr Ste 100
- 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
- Postal code
- 77478-2576
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1335-2020
- Classification
- Class III
- Recalling firm
- QuVa Pharma, Inc.
- Product quantity
- 17,050 syringes
- Termination date
- Jan 13, 2021
- Reason for recall
- Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the US.
- Recall initiation date
- Apr 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2020