Recalls / Class II
Class IID-0556-2020
Product
fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43
- Affected lot / code info
- Lots: 10029772 Exp. 11/17/2019, 10030627 Exp. 11/22/2019, 10030626 Exp. 11/21/2019, 10030408 Exp. 11/25/2019, 10030512 Exp. 11/27/2019, 10030408 Exp. 11/25/2019, 10031107 Exp. 12/5/2019, 10031268 Exp. 12/10/2019, 10031437 Exp. 12/15/2019, 10031821 Exp. 12/23/2019, 10032285 Exp. 12/30/2019
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-0556-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.