PlainRecalls
FDA Drug Moderate Class II Terminated

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75

Reported: December 21, 2016 Initiated: November 18, 2016 #D-0190-2017

Product Description

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75

Reason for Recall

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Details

Recalling Firm
Cantrell Drug Company
Units Affected
2889 bags
Distribution
Nationwide
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75. Recalled by Cantrell Drug Company. Units affected: 2889 bags.
Why was this product recalled?
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 21, 2016. Severity: Moderate. Recall number: D-0190-2017.