Why it was recalled
Lack of Assurance of Sterility
Product description
Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72
Lot numbers, UPCs & expiration codes
All Sterile Compounded Products within Expiry
Where it was sold
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
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-1335-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 20, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 1675
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmakon Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1335-2016, exactly as published.
Show all FDA fields
- City
- Noblesville
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 73960
- Address
- 14450 Getz Rd
- Code information
- All Sterile Compounded Products within Expiry
- Postal code
- 46060-3303
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1335-2016
- Classification
- Class II
- Recalling firm
- Pharmakon Pharmaceuticals, Inc.
- Product quantity
- 1675
- Termination date
- Jan 11, 2018
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72
- Distribution pattern
- Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
- Recall initiation date
- Apr 20, 2016
- Initial firm notification
- Press Release
- Center classification date
- Jul 11, 2016