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Recall Observatory FDA recall evidence

Drug product

Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14

D-1453-2014

May 15, 2014

Class II

Product summary

Firm
Franck's Lab Inc dba Trinity Care Solutions
Event
Event 68497
Status
Ongoing
Classification
Class II
Quantity
7 units
Official record key
drug-enforcement:D-1453-2014

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 29184 Exp 5/28/14

Distribution pattern: Florida

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility