Home / Recalls / QuVa Pharma, Inc. / D-0561-2020

D-0561-2020 Class II Terminated

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

FDA drug recall D-0561-2020 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 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36

Reason for Recall

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

Distribution Pattern

Nationwide.

Code Information

Lots: 10029291 Exp. 11/14/2019 10029292 Exp. 11/14/2019 10029977 Exp. 11/20/2019 10030041 Exp. 11/21/2019 10029977 Exp. 11/20/2019 10029978 Exp. 11/21/2019 10029979 Exp. 11/21/2019 10030041 Exp. 11/21/2019 10030043 Exp. 11/21/2019 10030396 Exp. 11/25/2019 10030960 Exp. 12/2/2019 10030961 Exp. 12/4/2019 10030962 Exp. 12/4/2019 10031010 Exp. 12/4/2019 10031011 Exp. 12/4/2019 10031012 Exp. 12/4/2019 10030960 Exp. 12/2/2019 10031086 Exp. 12/6/2019 10030960 Exp. 12/2/2019 10031263 Exp. 12/10/2019 10031262 Exp. 12/10/2019 10031413 Exp. 12/15/2019 10031463 Exp. 12/16/2019 10031696 Exp. 12/22/2019 10031947 Exp. 12/26/2019 10031948 Exp. 12/31/2019 10032414 Exp. 1/2/2020 10031978 Exp. 1/1/2020 10031948 Exp. 12/31/2019 10032412 Exp. 1/2/2020 10032413 Exp. 1/2/2020 10032687 Exp. 1/8/2020 10032723 Exp. 1/9/2020 10033037 Exp. 1/23/2020 10032929 Exp. 1/26/2020

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