D-1081-2020 Class II Terminated
FDA drug recall D-1081-2020 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: 1075 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
- 1075 units
Product Description
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
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
193500004D 3/16/2020 193510006D 3/17/2020 193530011D 3/19/2020 193570003D 3/23/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1081-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026