Recalls / Class II

Class IID-1468-2014

Product

Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15

Affected lot / code info

Rx # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15

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

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-1468-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.