Reported Aug 22, 2012 · Terminated

MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC…

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?

  • MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS)
Lot codes and dates
  • Rx #'s:

    153 of 153 codes

    • 0406657
    • 0405526
    • 0391965
    • 0393529
    • 0390040
    • 0362442
    • 0370756
    • 0378145
    • 0386548
    • 0393611
    • 0394410
    • 0394751
    • 0394753
    • 0395981
    • 0397434
    • 0398818
    • 0399650
    • 0399825
    • 0399848
    • 0399854
    • 0400112
    • 0401949
    • 0404137
    • 0404138
    • 0404295
    • 0405528
    • 0405700
    • 0407504
    • 0407507
    • 0407770
    • 0408225
    • 0408229
    • 0408670
    • 0410088
    • 0370756
    • 0376063
    • 0391443
    • 0397137
    • 0397222
    • 0397227
    • 0402055
    • 0406817
    • 0391443
    • 0362442
    • 0375777
    • 0390216
    • 0392072
    • 0392079
    • 0392091
    • 0395270
    • 0395277
    • 0395284
    • 0398284
    • 0400112
    • 0403421
    • 0370756
    • 0391443
    • 0362395
    • 0374541
    • 0375777
Amount recalled
188 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?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 5:46 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.