Home / Recalls / QuVa Pharma, Inc. / D-0547-2020

D-0547-2020 Class II Terminated

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

FDA drug recall D-0547-2020 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 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019, 10030008 Exp. 11/24/2019, 10029946 Exp. 11/21/2019, 10030009 Exp. 11/24/2019, 10030010 Exp. 11/24/2019, 10030483 Exp. 11/27/2019, 10030482 Exp. 11/27/2019, , 10030958 Exp. 12/3/2019, , 10030908 Exp. 12/2/2019, 10030430 Exp. 11/26/2019, 10030989 Exp. 12/4/2019, 10030959 Exp. 12/3/2019, 10030907 Exp. 12/2/2019, 10030908 Exp. 12/2/2019, 10031283 Exp. 12/11/2019, 10031345 Exp. 12/12/2019, 10031346 Exp. 12/12/2019, 10031477 Exp. 12/16/2019, 10031433 Exp. 12/15/2019, 10031434 Exp. 12/15/2019, 10031478 Exp. 12/16/2019, 10031568 Exp. 12/18/2019, 10031615 Exp. 12/19/2019, 10031479 Exp. 12/18/2019, 10031568 Exp. 12/18/2019, 10031569 Exp. 12/18/2019, 10031570 Exp. 12/18/2019, 10031642 Exp. 12/20/2019, 10031591 Exp. 12/19/2019, 10031813 Exp. 12/23/2019, 10031814 Exp. 12/23/2019, 10032008 Exp. 12/27/2019, 10032009 Exp. 12/27/2019, 10031759 Exp. 12/26/2019, 10031946 Exp. 12/26/2019, 10031846 Exp. 12/24/2019, 10032250 Exp. 12/30/2019, 10031845 Exp. 12/24/2019, 10031846 Exp. 12/24/2019, 10032366 Exp. 1/1/2020, 10032391 Exp. 1/1/2020, , 10032333 Exp. 12/31/2019, 10032445 Exp. 1/2/2020, 10031760 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10032664 Exp. 1/8/2020, 10032665 Exp. 1/8/2020, 10032533 Exp. 1/7/2020, , 10032614 Exp. 1/7/2020, 10032615 Exp. 1/7/2020

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-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-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-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-0554-2020 Class II — fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) (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