Recalls / Class II
Class IID-0728-2020
Product
FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
- Affected lot / code info
- Lots: 12122019@18 Exp. 12/21/2019; 12162019@24 Exp. 12/25/2019
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Assurance Infusion
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2626 S Loop W Ste 555, Houston, Texas 77054-2652
Distribution
- Quantity
- 2 syringe
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-12-20
- FDA classified
- 2020-01-13
- Posted by FDA
- 2020-01-22
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0728-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.