Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Product description
GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Lot numbers, UPCs & expiration codes
All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15
Where it was sold
U.S. Including: VA, NC
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-0641-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 18, 2015
- FDA report date
- Feb 3, 2016
- Quantity
- a) 11 bags, b) 9 Bags, c) 3 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sentara Enterprises
Original FDA data
Every field from FDA enforcement report D-0641-2016, exactly as published.
Show all FDA fields
- City
- Chesapeake
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 72746
- Address
- 535 Independence Pkwy Ste 300
- Code information
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15
- Postal code
- 23320-5176
- Report date
- Feb 3, 2016
- Product type
- Drugs
- Recall number
- D-0641-2016
- Classification
- Class II
- Recalling firm
- Sentara Enterprises
- Product quantity
- a) 11 bags, b) 9 Bags, c) 3 Bags
- Termination date
- Jun 29, 2016
- Reason for recall
- Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Distribution pattern
- U.S. Including: VA, NC
- Recall initiation date
- Sep 18, 2015
- Initial firm notification
- Center classification date
- Jan 28, 2016