Recalls / Class II
Class IID-1332-2022
Product
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
- Affected lot / code info
- Lot #: CHL, Exp. Date Dec 29, 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
- 360 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-1332-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.