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Recall Observatory FDA recall evidence

Drug product

Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15

D-1468-2014

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
Unavailable
Official record key
drug-enforcement:D-1468-2014

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 # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15

Distribution pattern: Florida

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility