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
METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE 10 ML METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE 10 ML 8 ML 8 MLS
Lot numbers, UPCs & expiration codes
Rx #'s: 0369092 0390078 0388491 0404406 0399651 0373092
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-1574-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2012
- FDA report date
- Aug 22, 2012
- 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-1574-2012, 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: 0369092 0390078 0388491 0404406 0399651 0373092
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1574-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- 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
- METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE 10 ML METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE 10 ML 8 ML 8 MLS
- 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