The Recall Desk

FDA (Drugs) recall action 68497

Franck's Lab Inc dba Trinity Care Solutions recalled 30 products on 2014-07-30

The FDA (Drugs) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.

Products
30
Announced
2014-07-30
Critical
0
Units
460

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–30 of 30

  • SevereFDA (Drugs)··2014-07-30

    Trinity Care Solutions Recalls Invanz Due to Sterility Concerns

    Trinity Care Solutions is recalling 12 units of compounded Invanz in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-07-30

    Trinity Care Solutions Recalls Cefazolin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Cefazolin 1 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.

    Product
    Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-07-30

    Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling Desferal sterile compounds due to quality control concerns identified during an FDA inspection.

    Product
    Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/100 mL 0.9%NS in Florida due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-07-30

    Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns

    Trinity Care Solutions is recalling 11 units of Cefepime 2 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.

    Product
    Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14
    Category
    Distribution
    1 state