Home / Recalls / QuVa Pharma, Inc. / D-0564-2020

D-0564-2020 Class II Terminated

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

FDA drug recall D-0564-2020 was initiated by QuVa Pharma, Inc. on November 12, 2019 and is designated Class II. Reason for recall: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules The recall status is terminated (terminated June 5, 2020).

Recall Details

Product Type
Drugs
Report Date
December 11, 2019
Initiation Date
November 12, 2019
Termination Date
June 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76

Reason for Recall

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Distribution Pattern

Nationwide.

Code Information

Lots: 10029361 Exp. 11/15/2019, 10029362 Exp. 11/15/2019, 10029334 Exp. 11/14/2019, 10029855 Exp. 11/19/2019, 10029856 Exp. 11/19/2019, 10030387 Exp. 11/25/2019, 10030388 Exp. 11/25/2019, 10031026 Exp. 12/12/2019, 10031078 Exp. 12/12/2019, 10031469 Exp. 12/16/2019, 10031493 Exp. 12/16/2019, 10031519 Exp. 12/17/2019, 10031804 Exp. 12/23/2019, 10031105 Exp. 12/12/2019, 10031830 Exp. 12/23/2019, 10031884 Exp. 12/24/2019, 10032704 Exp. 1/8/2020, 10032888 Exp. 1/12/2020, 10032889 Exp. 1/12/2020, 10032913 Exp. 1/13/2020, 10032939 Exp. 1/13/2020, 10032940 Exp. 1/13/2020

Other recalls by QuVa Pharma, Inc.

  • D-0664-2026 Class II — Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Comp (June 24, 2026)
  • 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-1335-2020 Class III — R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride sol (April 23, 2020)
  • 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-0570-2020 Class II — fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA P (November 12, 2019)

FDA data resources