Cefepime 2 gm/100 mL D5W — Class II drug recall D-1457-2014
Ongoing recall by Franck's Lab Inc dba Trinity Care Solutions, reported 2014-07-30, distributed in FL. Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subj
| Recall number | D-1457-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Franck's Lab Inc dba Trinity Care Solutions, Ocala, FL, United States |
| Recall initiated | 2014-05-15 |
| Classified | 2014-07-24 |
| Reported by FDA | 2014-07-30 |
| Distributed | FL |
| Quantity | 24 units |
| Reason classes | sterility |
| Expiration dates | 2014-02-04, 2014-05-17, 2014-05-21 |
Product
Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1457-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.