Recalls / Class II
Class IID-0562-2020
Product
fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
- Affected lot / code info
- Lots: 10029343 Exp. 11/15/2019, 10029344 Exp. 11/15/2019, 10029345 Exp. 11/15/2019, 10029895 Exp. 11/20/2019, 10029918 Exp. 11/20/2019, 10029919 Exp. 11/20/2019, 10029895 Exp. 11/20/2019, 10030398 Exp. 11/25/2019, 10030399 Exp. 11/25/2019, 10030400 Exp. 11/25/2019, 10031089 Exp. 12/6/2019, 10031059 Exp. 12/5/2019, 10031060 Exp. 12/5/2019, 10031061 Exp. 12/5/2019, 10031326 Exp. 12/12/2019, 10031327 Exp. 12/12/2019, 10031507 Exp. 12/17/2019, 10031480 Exp. 12/19/2019, 10031618 Exp. 12/19/2019, 10031619 Exp. 12/19/2019, 10031672 Exp. 12/20/2019, 10031618 Exp. 12/19/2019, 10031504 Exp. 12/18/2019, 10031733 Exp. 12/22/2019, 10031734 Exp. 12/22/2019, 10031672 Exp. 12/20/2019, 10031815 Exp. 12/23/2019, 10031505 Exp. 12/18/2019, 10031506 Exp. 12/17/2019, 10031328 Exp. 12/12/2019, 10031816 Exp. 12/23/2019, 10031897 Exp. 12/25/2019, 10031919 Exp. 12/25/2019, 10031847 Exp. 12/24/2019, 10031791 Exp. 12/23/2019, 10031792 Exp. 12/23/2019, 10031793 Exp. 12/23/2019, 10031817 Exp. 12/23/2019, 10032279 Exp. 12/31/2019, 10031847 Exp. 12/24/2019, 10032279 Exp. 12/31/2019, 10032334 Exp. 12/31/2019, 10032368 Exp. 1/1/2020, 10032392 Exp. 1/1/2020, 10032278 Exp. 12/31/2019, 10032251 Exp. 12/30/2019, 10032252 Exp. 12/30/2019, 10032930 Exp. 1/13/2020, 10032850 Exp. 1/12/2020, 10032584 Exp. 1/6/2020, 10032850 Exp. 1/12/2020, 10032900 Exp. 1/13/2020, 10032583 Exp. 1/7/2020, 10032901 Exp. 1/13/2020, 10032931 Exp. 1/16/2020, 10032900 Exp. 1/13/2020
Why it was recalled
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Recalling firm
- Firm
- QuVa Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr Ste 100, Sugar Land, Texas 77478-2576
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-11-12
- FDA classified
- 2019-12-03
- Posted by FDA
- 2019-12-11
- Terminated
- 2020-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0562-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.