Home / Recalls / QuVa Pharma, Inc. / D-0562-2020

D-0562-2020 Class II Terminated

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

FDA drug recall D-0562-2020 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) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Lots: 10029343 Exp. 11/15/2019, 10029344 Exp. 11/15/2019, 10029345 Exp. 11/15/2019, 10029895 Exp. 11/20/2019, 10029918 Exp. 11/20/2019, 10029919 Exp. 11/20/2019, 10029895 Exp. 11/20/2019, 10030398 Exp. 11/25/2019, 10030399 Exp. 11/25/2019, 10030400 Exp. 11/25/2019, 10031089 Exp. 12/6/2019, 10031059 Exp. 12/5/2019, 10031060 Exp. 12/5/2019, 10031061 Exp. 12/5/2019, 10031326 Exp. 12/12/2019, 10031327 Exp. 12/12/2019, 10031507 Exp. 12/17/2019, 10031480 Exp. 12/19/2019, 10031618 Exp. 12/19/2019, 10031619 Exp. 12/19/2019, 10031672 Exp. 12/20/2019, 10031618 Exp. 12/19/2019, 10031504 Exp. 12/18/2019, 10031733 Exp. 12/22/2019, 10031734 Exp. 12/22/2019, 10031672 Exp. 12/20/2019, 10031815 Exp. 12/23/2019, 10031505 Exp. 12/18/2019, 10031506 Exp. 12/17/2019, 10031328 Exp. 12/12/2019, 10031816 Exp. 12/23/2019, 10031897 Exp. 12/25/2019, 10031919 Exp. 12/25/2019, 10031847 Exp. 12/24/2019, 10031791 Exp. 12/23/2019, 10031792 Exp. 12/23/2019, 10031793 Exp. 12/23/2019, 10031817 Exp. 12/23/2019, 10032279 Exp. 12/31/2019, 10031847 Exp. 12/24/2019, 10032279 Exp. 12/31/2019, 10032334 Exp. 12/31/2019, 10032368 Exp. 1/1/2020, 10032392 Exp. 1/1/2020, 10032278 Exp. 12/31/2019, 10032251 Exp. 12/30/2019, 10032252 Exp. 12/30/2019, 10032930 Exp. 1/13/2020, 10032850 Exp. 1/12/2020, 10032584 Exp. 1/6/2020, 10032850 Exp. 1/12/2020, 10032900 Exp. 1/13/2020, 10032583 Exp. 1/7/2020, 10032901 Exp. 1/13/2020, 10032931 Exp. 1/16/2020, 10032900 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