Reported Aug 22, 2012 · Terminated

THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138

Is this the product you have?

  • THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS 8 VIALS (13 DIFFERENT PRODUCTS)
Lot codes and dates
  • Rx #'s:
    • 0385046
    • 0406983
    • 0367360
    • 0384324
    • 0406983
    • 0397099
    • 0398852
    • 0398855
    • 0398856
    • 0405772
    • 0406983
    • 0390146
    • 0398705
    • 0398707
    • 0398709
    • 0398717
    • 0398721
    • 0398732
    • 0377099
    • 0377104
    • 0384258
    • 0384317
    • 0390142
    • 0390148
    • 0390154
    • 0390160
    • 0390163
    • 0390146
    • 0404961
    • 0369755
    • 0377099
    • 0377101
    • 0377104
    • 0380763
    • 0384258
    • 0384323
    • 0384324
    • 0390142
    • 0390148
    • 0391675
    • 0400729
    • 0405530
    • 0377099
    • 0377101
    • 0377104
    • 0380763
Amount recalled
53 units

This recall covers 198 products

The agency filed one notice per product. You are reading one of them; the other 197 are below.

185 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 15, 2014 · Data as of Sep 19, 6:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.