D-0962-2018 Class II Terminated
FDA drug recall D-0962-2018 was initiated by Avella Of Deer Valley, Inc. Store 38 on Jun 12, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential leakage of bags. The recall status is terminated (terminated Jan 24, 2020). Affected quantity: 120 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 25, 2018
- Initiation Date
- Jun 12, 2018
- Termination Date
- Jan 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 bags
Product Description
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 5/22/18 1012 495-89425P, BUD 7/21/2018; 6/5/18 0302 495-89425P, BUD 8/4/2018. .
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0962-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026