D-1082-2020 Class II Terminated
FDA drug recall D-1082-2020 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: 80 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
- 80 units
Product Description
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
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
193540006D, 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-1082-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026