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Recall Observatory FDA recall evidence

Drug product

Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14

D-1474-2014

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
16 units
Official record key
drug-enforcement:D-1474-2014

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 # 28878, Exp 05/16/14

Distribution pattern: Florida

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility