Why it was recalled
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Product description
FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lot numbers, UPCs & expiration codes
All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@7
Where it was sold
Hospitals, clinics, physicians, and patients in the Michigan area only.
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-420-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 700 mL
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Specialty Medicine Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-420-2014, exactly as published.
Show all FDA fields
- City
- South Lyon
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 66566
- Address
- 350 S Lafayette St
- Code information
- All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 10042013@7
- Postal code
- 48178-1814
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-420-2014
- Classification
- Class II
- Recalling firm
- Specialty Medicine Compounding Pharmacy
- Product quantity
- 700 mL
- Termination date
- Sep 22, 2014
- Reason for recall
- Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Distribution pattern
- Hospitals, clinics, physicians, and patients in the Michigan area only.
- Recall initiation date
- Oct 19, 2013
- Initial firm notification
- Press Release
- Center classification date
- Jan 10, 2014