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
FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML, 600 ML; FLUOROURACIL SOLUTION PF 1% OPHTHALMIC 10 ML, 20 ML, 25 ML, 5 ML; FLUOROURACIL, P.F. 1% INJECTABLE 40 ML (12 DIFFERENT PRODUCTS)
Lot numbers, UPCs & expiration codes
Rx #'s: 0397776 0377720 0388566 0388566 0379930 0396960 0402574 0379930 0391427 0391427 0391427 0391427 0408750
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-1520-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 25, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 14 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-1520-2012, 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: 0397776 0377720 0388566 0388566 0379930 0396960 0402574 0379930 0391427 0391427 0391427 0391427 0408750
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1520-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 14 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
- FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML, 600 ML; FLUOROURACIL SOLUTION PF 1% OPHTHALMIC 10 ML, 20 ML, 25 ML, 5 ML; FLUOROURACIL, P.F. 1% INJECTABLE 40 ML (12 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