Recalls / Class II
Class IID-0554-2020
Product
fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76
- Affected lot / code info
- Lots: 10029307 Exp. 11/14/2019, 10029939 Exp. 11/20/2019, 10029884 Exp. 11/19/2019, 10029915 Exp. 11/20/2019, 10030385 Exp. 11/25/2019, 10030386 Exp. 11/25/2019, 10030923 Exp. 12/11/2019, 10031320 Exp. 12/11/2019, 10031025 Exp. 12/12/2019, 10031024 Exp. 12/12/2019, 10032678 Exp. 1/8/2020, 10032993 Exp. 1/14/2020
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-0554-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.