Home / Recalls / QuVa Pharma, Inc. / D-0549-2020

D-0549-2020 Class II Terminated

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

FDA drug recall D-0549-2020 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) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Lots: 10029288 Exp. 11/14/2019, 10029762 Exp. 11/14/2019, 10029788 Exp. 11/18/2019, 10029838 Exp. 11/19/2019, 10029948 Exp. 11/21/2019, 10029949 Exp. 11/21/2019, 10030337 Exp. 11/24/2019, 10029838 Exp. 11/19/2019, 10030539 Exp. 11/28/2019, 10030943 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030963 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030888 Exp. 12/2/2019, 10030963 Exp. 12/3/2019, 10031129 Exp. 12/8/2019, 10031284 Exp. 12/11/2019, 10031414 Exp. 12/15/2019, 10031435 Exp. 12/16/2019, 10031735 Exp. 12/22/2019, 10032253 Exp. 12/30/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10032280 Exp. 12/31/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10033009 Exp. 1/15/2020, 10032585 Exp. 1/14/2020, 10033009 Exp. 1/15/2020

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-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