FDAFDA · Food and drugs·Recall number D-1469-2014
Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14
Published July 30, 2014 · Recall initiated: May 15, 2014
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Distributor
- Florida
- Lot
- Rx # 28300, Exp 02/7/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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