Recalls / Class II
Class IID-1331-2022
Product
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
- Affected lot / code info
- Lot #: CHI, Exp. Date Dec 22, 2022
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SterRx, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 141 Idaho Ave, Plattsburgh, New York 12903-3987
Distribution
- Quantity
- 720 bags
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-07-25
- FDA classified
- 2022-08-09
- Posted by FDA
- 2022-08-17
- Terminated
- 2023-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1331-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.