D-0311-2022 Class II Terminated
FDA drug recall D-0311-2022 was initiated by SterRx, LLC on Nov 12, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Dec 6, 2023). Affected quantity: 684 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 5, 2022
- Initiation Date
- Nov 12, 2021
- Termination Date
- Dec 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 684 bags
Product Description
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
S21335/BZV
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0311-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026