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

D-0561-2020 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) 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-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-0571-2020 Class II — fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preserv (November 12, 2019)
  • 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-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)