FDA-Drug2014-07-30Class II

Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14

Franck's Lab Inc dba Trinity Care Solutions
Hazard

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.

Sold states
Florida
Affected count
10 units
Manufactured in
202 SW 17th St Suite C, Ocala, FL, United States
Products
Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1476-2014

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