Home / Recalls / New England Compounding Center / D-119-2013

D-119-2013 Class II Terminated

Recalled by New England Compounding Center — Framingham, MA

Recall Details

Product Type
Drugs
Report Date
January 9, 2013
Initiation Date
September 26, 2012
Termination Date
October 7, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7055 vials

Product Description

Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

All lot codes

Other recalls by New England Compounding Center

  • D-053-2013 Class II — All Non Sterile Products manufactured by NECC (New England Compounding Center), (October 6, 2012)
  • D-052-2013 Class II — All Sterile Products manufactured by NECC (New England Compounding Center), Fram (October 6, 2012)
  • D-112-2013 Class II — Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/ (September 26, 2012)
  • D-120-2013 Class II — Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, F (September 26, 2012)
  • D-110-2013 Class I — Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and (September 26, 2012)
  • D-123-2013 Class II — Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compound (September 26, 2012)
  • D-118-2013 Class II — Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New Engl (September 26, 2012)
  • D-117-2013 Class II — Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compoun (September 26, 2012)
  • D-116-2013 Class II — Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL P (September 26, 2012)
  • D-113-2013 Class II — Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosph (September 26, 2012)