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Class II: temporary or reversible health riskTerminated

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

LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab · Ocala, FL

Risk level
Class II
Reported by FDA
Aug 22, 2012
Recall ID
D-1555-2012
Check your lot numberHow we source this data

Summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled Leucovorin starting May 21, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1555-2012 on Aug 22, 2012. Reason: 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. Status: Terminated.

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

LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 8 VIAL; LEUCOVORIN, LYOPHILIZED 500 MG VIAL INJECTABLE 10 VIAL 14 VIAL 15 VIAL 17 VIAL 2 VIAL 20 VIAL 23 VIAL 25 VIAL 27 VIAL 3 VIAL 30 VIAL 33 VIAL 36 VIAL 5 VIAL 50 VIAL (35 DIFFERENT PRODUCTS)

Lot numbers, UPCs & expiration codes

Rx #'s: 0403290 0405427 0382085 0403290 0382085 0405142 0391560 0391560 0382085 0362356 0362504 0376747 0398606 0405426 0362504 0362504 0376747 0402778 0405426 0395599 0395599 0405112 0406366 0388985 0391567 0396672 0405426 0395599 0398606 0360280 0385032 0390726 0402210 0398232 0360280 0362394 0393068 0403288 0360025 0369905 0379934 0393068 0402985 0403256 0399150 0360025 0372389 0399150 0402985 0399150 0403288 0372389 0393068 0398232 0360280 0362394 0393068 0398232

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-1555-2012
Classification
Class II
Status
Terminated
Recall initiated
May 21, 2012
FDA report date
Aug 22, 2012
Quantity
72 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-1555-2012, 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: 0403290 0405427 0382085 0403290 0382085 0405142 0391560 0391560 0382085 0362356 0362504 0376747 0398606 0405426 0362504 0362504 0376747 0402778 0405426 0395599 0395599 0405112 0406366 0388985 0391567 0396672 0405426 0395599 0398606 0360280 0385032 0390726 0402210 0398232 0360280 0362394 0393068 0403288 0360025 0369905 0379934 0393068 0402985 0403256 0399150 0360025 0372389 0399150 0402985 0399150 0403288 0372389 0393068 0398232 0360280 0362394 0393068 0398232
Postal code
34474-5138
Report date
Aug 22, 2012
Product type
Drugs
Recall number
D-1555-2012
Classification
Class II
Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Product quantity
72 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
LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 8 VIAL; LEUCOVORIN, LYOPHILIZED 500 MG VIAL INJECTABLE 10 VIAL 14 VIAL 15 VIAL 17 VIAL 2 VIAL 20 VIAL 23 VIAL 25 VIAL 27 VIAL 3 VIAL 30 VIAL 33 VIAL 36 VIAL 5 VIAL 50 VIAL (35 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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1555-2012, published Aug 22, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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