Home / Recalls / QuVa Pharma, Inc. / D-0568-2020

D-0568-2020 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 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Lots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020

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-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-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-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)