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
VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML 180 ML 90 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML 20 ML 40 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6/ASCORBIC ACID/B12) 12.5/2/12.5/5/5/1MG/1MG/ML 60 ML VITAMIN B COMPLEX -PF (B1,B2,B3,B5,B6) 12.5/12.5/12.5/12.5/12.5MG/ML INJECTABLE 40 ML VITAMIN B COMPLEX PF (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML VITAMIN B-6/VITAMIN B-12 100MG/1000MCG/ML INJECTABLE 5 ML VITAMIN B-COMPLEX 100*** (30ML) INJECTABLE 30 ML VITAMIN COMPLEX (ASCOR,B1,B2,B3,B5,B6,B12,METH,INOS,CHL,LID) DR. HOLLOWAY INJECT 180 ML 240 ML 30 ML 60 ML VITAMIN D3 IN SESAME OIL 10,000 IU/ML INJECTABLE 60 ML (23 DIFFERENT PRODUCTS)
Lot numbers, UPCs & expiration codes
Rx #'s: 0396112 0396112 0390633 0399923 0392295 0397930 0405691 0357875 0371933 0370806 0371933 0357875 0371933 0373258 0373258 0373258 0391775 0397909 0391540 0371152 0401946 0409588 0391886 0391886 0391886 0391886 0391867 0400517
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-1641-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 21, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 38 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-1641-2012, 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: 0396112 0396112 0390633 0399923 0392295 0397930 0405691 0357875 0371933 0370806 0371933 0357875 0371933 0373258 0373258 0373258 0391775 0397909 0391540 0371152 0401946 0409588 0391886 0391886 0391886 0391886 0391867 0400517
- Postal code
- 34474-5138
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1641-2012
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Product quantity
- 38 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
- VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML 180 ML 90 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML 20 ML 40 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6/ASCORBIC ACID/B12) 12.5/2/12.5/5/5/1MG/1MG/ML 60 ML VITAMIN B COMPLEX -PF (B1,B2,B3,B5,B6) 12.5/12.5/12.5/12.5/12.5MG/ML INJECTABLE 40 ML VITAMIN B COMPLEX PF (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML VITAMIN B-6/VITAMIN B-12 100MG/1000MCG/ML INJECTABLE 5 ML VITAMIN B-COMPLEX 100*** (30ML) INJECTABLE 30 ML VITAMIN COMPLEX (ASCOR,B1,B2,B3,B5,B6,B12,METH,INOS,CHL,LID) DR. HOLLOWAY INJECT 180 ML 240 ML 30 ML 60 ML VITAMIN D3 IN SESAME OIL 10,000 IU/ML INJECTABLE 60 ML (23 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