D-1093-2020 Class II Terminated
FDA drug recall D-1093-2020 was initiated by PharMEDium Services, LLC on Mar 16, 2020 and is designated Class II. Reason for recall: Firm is recalling 46 lots of various products because of a lack of sterility assurance. The recall status is terminated (terminated Feb 14, 2025). Affected quantity: 1350 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 15, 2020
- Initiation Date
- Mar 16, 2020
- Termination Date
- Feb 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1350 units
Product Description
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
Reason for Recall
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Distribution Pattern
Distributed Nationwide in the US
Code Information
193520008D, Exp 3/18/2020 193540005D, Exp 3/22/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1093-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026