Recalls / Class II
Class IID-0322-2022
Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
- Affected lot / code info
- S21082/BQV 13-Nov-21 S21102/BRM 28-Nov-21 S21135/BST 14-Dec-21 S21166/BTX 7-Jan-22 S21178/BUJ 28-Jan-22 S21226/BVZ 5-Feb-22 S21237/BWI 7-Feb-22 S21242/BWM 13-Feb-22 S21280/BXX 11-Mar-22 S21302/BYS 21-Mar-22 S21345/CAE 23-Apr-22 S21424/CDG 28-May-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
- 36,576 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-0322-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.