FDA Drug Recalls

Recalls / Class II

Class IID-1160-2016

Product

HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163

Affected lot / code info
Lot: 6146, exp 9/5/15

Why it was recalled

Stability Data Does Not Support Expiry

Recalling firm

Firm
Cantrell Drug Company
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
7321 Cantrell Rd, N/A, Little Rock, Arkansas 72207-4144

Distribution

Quantity
4170 syringes
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-08-21
FDA classified
2016-07-06
Posted by FDA
2016-07-13
Terminated
2017-02-03
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1160-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls