FDA Drug Recalls

Recalls / Class II

Class IID-1169-2015

Product

CefTRIAXone Sodium, Ceftriaxone 1 gram / NS 50 mL, Qty: 10 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

Affected lot / code info
Compounded on 05/29/15, Discard After: 06/08/15

Why it was recalled

Lack of Assurance of Sterility: Sterility of product is not assured.

Recalling firm

Firm
Lincare, Inc.
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
1527 S Bowman Rd Ste D, Little Rock, Arkansas 72211-4200

Distribution

Quantity
10 Bags
Distribution pattern
United States including: Arkansas

Timeline

Recall initiated
2015-05-28
FDA classified
2015-07-01
Posted by FDA
2015-07-08
Terminated
2017-02-16
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1169-2015. 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