D-1479-2014 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 30, 2014
- Initiation Date
- May 15, 2014
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 units
Product Description
Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14
Reason for Recall
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.
Distribution Pattern
Florida
Code Information
Rx # 29011, Exp 05/21/14; Rx # 29141, Exp 05/22/14; Rx # 29171, Exp 05/20/14