Recalls / Class II
Class IID-0552-2020
Product
fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37
- Affected lot / code info
- Lots: 10029346 Exp. 11/15/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10030017 Exp. 11/24/2019, 10029982 11/22/2019, 10030017 Exp. 11/24/2019, 10030401 Exp. 11/25/2019, 10030017 Exp. 11/24/2019, 10031092 Exp. 12/6/2019, 10030401 Exp. 11/25/2019, 10031092 12/6/2019, 10031349 Exp. 12/12/2019, 10032011 Exp. 12/27/2019, 10032012 Exp. 12/27/2019, 10032505 Exp. 1/5/2020, 10032447 Exp. 1/2/2020, 10032932 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-0552-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.