PlainRecalls
FDA Drug Moderate Class II Ongoing

Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14

Reported: July 30, 2014 Initiated: May 15, 2014 #D-1477-2014

Product Description

Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14

Reason for Recall

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Details

Units Affected
8 units
Distribution
Florida
Location
Ocala, FL

Frequently Asked Questions

What product was recalled?
Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14. Recalled by Franck's Lab Inc dba Trinity Care Solutions. Units affected: 8 units.
Why was this product recalled?
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 30, 2014. Severity: Moderate. Recall number: D-1477-2014.