Recalls / Class II

Class IID-1457-2014

Product

Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14

Affected lot / code info

Rx # 28288, Exp 02/4/14; Rx # 29176, Exp 05/21/14; Rx # 28829, Exp 05/17/14

Why it was 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.

Recalling firm

Firm

Franck's Lab Inc dba Trinity Care Solutions

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

202 SW 17th St Suite C, Ocala, Florida 34471-8138

Distribution

Quantity

24 units

Distribution pattern

Florida

Timeline

Recall initiated

2014-05-15

FDA classified

2014-07-24

Posted by FDA

2014-07-30

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1457-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.