D-0947-2018 Class II Terminated
FDA drug recall D-0947-2018 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: 900 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
- 900 bags
Product Description
HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 138-20181105@65,138-20181105@64, 138-20181105@63, BUD 8/19/2018.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0947-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026