D-1454-2014 Class II Ongoing
FDA drug recall D-1454-2014 was initiated by Franck's Lab Inc dba Trinity Care Solutions on May 15, 2014 and is designated Class II. 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 contr… The recall status is ongoing. Affected quantity: 22 units.
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
- 22 units
Product Description
Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14
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 # 28289, Exp 02/5/14; Rx # 29189, Exp 05/23/14