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.
Product description
TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1631-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 64 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Original FDA data
Every field from FDA enforcement report D-1631-2012, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62443
- Address
- 1210 SW 33rd Avenue
- Code information
- 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
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1631-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 64 units
- Termination date
- Aug 15, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Recall initiation date
- May 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2012