Home / Recalls / QuVa Pharma, Inc. / D-0559-2020

D-0559-2020 Class II Terminated

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

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 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Lots: 10029914 Exp. 11/20/2019, 10030342 Exp. 11/24/2019, 10030948 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10030949 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10031377 Exp. 12/6/2019, 10031141 Exp. 12/9/2019, 10031423 Exp. 12/15/2019, 10031627 Exp. 12/19/2019, 10031709 Exp. 12/22/2019, 10031907 Exp. 12/25/2019, 10032022 Exp. 12/27/2019, 10031858 Exp. 12/24/2019, 10032381 Exp. 1/1/2020, 10032296 Exp. 12/31/2019, 10032268 Exp. 12/30/2019, 10032467 Exp. 1/2/2020, 10032674 Exp. 1/8/2020, 10032569 Exp. 1/6/2020, 10032570 Exp. 1/6/2020, 10032516 Exp. 1/5/2020, 10032517 Exp. 1/5/2020, 10032674 Exp. 1/8/2020, 10032570 Exp. 1/6/2020, 10032675 Exp. 1/8/2020, 10033019 Exp. 1/15/2020,

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-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-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-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-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-0555-2020 Class II — fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, (November 12, 2019)