Drug product
ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15
D-1470-2014
Product summary
- Event
- Event 68497
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
drug-enforcement:D-1470-2014
Official wording
Reason: 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.
Code information: Rx # 28838, Exp 03/4/15
Distribution pattern: Florida
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility