D-0193-2017 Class II Terminated
FDA drug recall D-0193-2017 was initiated by Cantrell Drug Company on November 18, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility - the firm is recalling select sterile drug products. The recall status is terminated (terminated April 29, 2020). Affected quantity: 150 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- December 21, 2016
- Initiation Date
- November 18, 2016
- Termination Date
- April 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 bags
Product Description
Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24
Reason for Recall
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Distribution Pattern
Nationwide
Code Information
Lot: 167081