🔍 RecallPedia

TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)

Class I - Dangerous
💊 Drugs Recalled: May 21, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab Compounded Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Rx #'s: T0372867 T0387431 T0388104 T0389467 T0389651 T0389841 T0391671 T0394240 T0395182 T0395583 T0396607 T0397069 T0397176 T0398192 T0399822 T0399900 T0400079 T0400081 T0400293 T0400444 T0400658 T0400794 T0400806 T0400871 T0401635 T0401644 T0401957 T0402166 T0402388 T0402390 T0402553 T0402656 T0402943 T0403559 T0405372 T0405460 T0406116 T0406555 T0406565 T0406984 T0407064 T0407383 T0407394 T0407440 T0407793 T0408122 T0408306 T0408399 T0408744 T0409050 T0409093 T0409107 T0409169 T0409178 T0396714 T0394672 T0395926 T0394672 T0394672 T0398564 T0394672
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)

Product Codes/Lot Numbers:

Rx #'s: T0372867 T0387431 T0388104 T0389467 T0389651 T0389841 T0391671 T0394240 T0395182 T0395583 T0396607 T0397069 T0397176 T0398192 T0399822 T0399900 T0400079 T0400081 T0400293 T0400444 T0400658 T0400794 T0400806 T0400871 T0401635 T0401644 T0401957 T0402166 T0402388 T0402390 T0402553 T0402656 T0402943 T0403559 T0405372 T0405460 T0406116 T0406555 T0406565 T0406984 T0407064 T0407383 T0407394 T0407440 T0407793 T0408122 T0408306 T0408399 T0408744 T0409050 T0409093 T0409107 T0409169 T0409178 T0396714 T0394672 T0395926 T0394672 T0394672 T0398564 T0394672

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1631-2012

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Class I - Dangerous

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.

May 21, 2012 Compounded Drugs Nationwide View Details →

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Class I - Dangerous

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

Class I - Dangerous

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.

May 25, 2012 Compounded Drugs Nationwide View Details →