Recalls / Class II
Class IID-0567-2020
Product
fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05
- Affected lot / code info
- Lots: 10029186 Exp. 11/18/2019, 10029791 Exp. 11/18/2019, 10030403 Exp. 11/25/2019, 10030456 Exp. 11/27/2019, 10030910 Exp. 12/2/2019, 10030403 Exp. 11/25/2019, 10031154 Exp. 12/8/2019, 10031238 Exp. 12/10/2019, 10031182 Exp. 12/9/2019, 10031130 Exp. 12/8/2019, 10031483 Exp. 12/16/2019, 10031482 Exp. 12/16/2019, 10031621 Exp. 12/19/2019, 10031592 Exp. 12/19/2019, 10031921 Exp. 12/25/2019, 10031869 Exp. 12/24/2019, 10032219 Exp. 12/29/2019, 10032393 Exp. 1/1/2020, 10032369 Exp. 1/1/2020, 10032561 Exp. 1/6/2020, 10032586 Exp. 1/6/2020, 10031898 Exp. 12/26/2019
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-0567-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.