D-0947-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2018
- Initiation Date
- June 12, 2018
- Termination Date
- January 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.