Recalls / Class II
Class IID-1478-2014
Product
Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14
- Affected lot / code info
- Rx # 29083, Exp 05/21/14
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
- 7 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-1478-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.