Recalls / Class II
Class IID-0321-2022
Product
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
- Affected lot / code info
- S21162/BTT 13-Nov-21 S21163/BTU 13-Nov-21 S21167/BTY 19-Nov-21 S21174/BUF 20-Nov-21 S21175/BUG 21-Nov-21 S21217/BVS 12-Dec-21 S21218/BVT 12-Dec-21 S21219/BVU 16-Dec-21 S21241/BWL 24-Dec-21 S21281/BXY 20-Jan-22 S21282/BXZ 23-Jan-22 S21283/BYA 22-Jan-22 S21297/BYN 28-Jan-22 S21340/CAA 27-Feb-22 S21342/CAC 5-Mar-22 S21352/CAL 6-Mar-22 S21359/CAS 11-Mar-22 S21362/CAV 12-Mar-22 S21368/CBB 13-Mar-22 S21369/CBC 19-Mar-22 S21415/CCX 7-Apr-22 S21419/CDB 7-Apr-22 S21434/CDP 16-Apr-22
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SterRx, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 141 Idaho Ave, Plattsburgh, New York 12903-3987
Distribution
- Quantity
- 74,508 bags
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2021-11-12
- FDA classified
- 2021-12-29
- Posted by FDA
- 2022-01-05
- Terminated
- 2023-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0321-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.