Drug product
Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14
D-1458-2014
Product summary
- Event
- Event 68497
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31 units
- Official record key
drug-enforcement:D-1458-2014
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 # 29039, Exp 05/05/14 & 05/20/14; Rx # 29204, Exp 05/23/14; Rx # 29161, Exp 05/19/14
Distribution pattern: Florida
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility