Home / Recalls / QuVa Pharma, Inc. / D-1335-2020

D-1335-2020 Class III Terminated

Recalled by QuVa Pharma, Inc. — Sugar Land, TX

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

Other recalls by QuVa Pharma, Inc.

  • D-0113-2026 Class II — R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamin (October 10, 2025)
  • D-0295-2025 Class II — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 m (March 6, 2025)
  • D-0296-2025 Class II — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 (March 6, 2025)
  • D-0297-2025 Class II — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 m (March 6, 2025)
  • D-1544-2022 Class III — oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injectio (September 20, 2022)
  • D-1302-2020 Class II — oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection (May 28, 2020)
  • D-0552-2020 Class II — fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) (November 12, 2019)
  • D-0566-2020 Class II — fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx (November 12, 2019)
  • D-0547-2020 Class II — fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 (November 12, 2019)
  • D-0569-2020 Class II — fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharm (November 12, 2019)