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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Franck's Lab Inc., d.b.a. Franck's Compounding Lab to request your refund or repair — edit it as you like.
Subject: Recall D-1513-2012 — Franck's Lab Inc., d.b.a. Franck's Compounding Lab Franck's Lab Inc., d.b.a. Franck's Compounding L Hello, I own a Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT) that is covered by recall D-1513-2012 from Franck's Lab Inc., d.b.a. Franck's Compounding Lab. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
