Recalls / Class II
Class IID-0305-2022
Product
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
- Affected lot / code info
- S21086/BQW 14-Dec-21 S21149/BTH 23-Jan-22 S21159/BTQ 30-Jan-22 S21265/BXI 3-Apr-22 S21305/BYU 24-Apr-22 S21311/BZA 26-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
- 18,948 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-0305-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.