D-1331-2022 Class II Terminated
FDA drug recall D-1331-2022 was initiated by SterRx, LLC on Jul 25, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Jun 22, 2023). Affected quantity: 720 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 17, 2022
- Initiation Date
- Jul 25, 2022
- Termination Date
- Jun 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 720 bags
Product Description
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: CHI, Exp. Date Dec 22, 2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1331-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026