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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Product description
FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT PRODUCTS)
Lot numbers, UPCs & expiration codes
Rx #'s:N0395099 N0389078 N0389083 N0389084 N0389085 N0389086 N0389089 N0389090 N0389093 N0389095 N0389097 N0389099 N0389100 N0390325 N0390326 N0390328 N0390329 N0390331 N0390332 N0390333 N0390338 N0390377 N0390380 N0390382 N0390383 N0390385 N0390390 N0390393 N0392339 N0392343 N0392344 N0392345 N0392347 N0392349 N0392351 N0392353 N0392354 N0392355 N0392357 N0392360 N0392363 N0392364 N0392367 N0392368 N0392370 N0392372 N0392374 N0392375 N0397646 N0397796 N0397797 N0397798 N0397802 N0397803 N0397804 N0397805 N0397806 N0397807 N0397990 N0397993 N0397994 N0397996 N0397997 N0398016 N0398017 N0398019 N0398020 N0398021 N0396955 N0398306 N0405187 N0401002 N0396784 N0398527 N0400271 N0400917 N0407735 N0409318 N0398310 N0408255 N0399153 N0404847 N0398297 N0399447 N0403452 N0406065 N0409741 N0397353 N0398612 N0406345 N0408105 N0393498 N0395106 N0401234 N0402072 N0402652 N0406677 N0397637 N0400888 N0398823 N0399918 N0400676 N0404455 N0398592 N0409187 N0393520 N0394243 N0406426 N0407548 N0397583
Where it was sold
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and 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-1518-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 25, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 110 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-1518-2012, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62416
- Address
- 1210 SW 33rd Avenue
- Code information
- Rx #'s:N0395099 N0389078 N0389083 N0389084 N0389085 N0389086 N0389089 N0389090 N0389093 N0389095 N0389097 N0389099 N0389100 N0390325 N0390326 N0390328 N0390329 N0390331 N0390332 N0390333 N0390338 N0390377 N0390380 N0390382 N0390383 N0390385 N0390390 N0390393 N0392339 N0392343 N0392344 N0392345 N0392347 N0392349 N0392351 N0392353 N0392354 N0392355 N0392357 N0392360 N0392363 N0392364 N0392367 N0392368 N0392370 N0392372 N0392374 N0392375 N0397646 N0397796 N0397797 N0397798 N0397802 N0397803 N0397804 N0397805 N0397806 N0397807 N0397990 N0397993 N0397994 N0397996 N0397997 N0398016 N0398017 N0398019 N0398020 N0398021 N0396955 N0398306 N0405187 N0401002 N0396784 N0398527 N0400271 N0400917 N0407735 N0409318 N0398310 N0408255 N0399153 N0404847 N0398297 N0399447 N0403452 N0406065 N0409741 N0397353 N0398612 N0406345 N0408105 N0393498 N0395106 N0401234 N0402072 N0402652 N0406677 N0397637 N0400888 N0398823 N0399918 N0400676 N0404455 N0398592 N0409187 N0393520 N0394243 N0406426 N0407548 N0397583
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1518-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 110 units
- Termination date
- Aug 13, 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 because 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
- FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT PRODUCTS)
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Recall initiation date
- May 25, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2012